Table, Obstetric (And Accessories)
FDA product code KNC · Class II (moderate risk) · 21 CFR 884.4900 · Obstetrics/Gynecology
26510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Adel Medical , Ltd. 3
- Hill-Rom, Inc. 2
- Pulley-Kellam Co., Inc. 1
- Luneau Gynecologie SA 1
- Graphic Controls Corp. 1
- Buckman Co., Inc. 1
- Stryker Corporation 1
- Ad-Tech Medical Instrument Corporation 1
- Global Medical Prods, Inc. 1
- Daun International, Inc. 1
- Shampaine/Wilson 1
- Mic Medical Corp. 1
- I E Industries 1
- Qulab Co. 1
- Amsco Co. 1
- S & W Enterprises, Inc. 1
- Latex Medical Devices, Inc. 1
- Lada Intl., Inc. 1
- Century Manufacturing Co. 1
- Ets Rene Marzet 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001261 | L720 Examination ChairKNC · Traditional | Luneau Gynecologie SA | 06/08/2000SE |
| K932035 | Non-Linting Delivery BlanketKNC · Traditional | Amsco Sterile Recoveries, Inc. | 05/26/1994SE |
| K924420 | Medical Disposable BeddingKNC · Traditional | Hill-Rom, Inc. | 12/10/1993SE |
| K914544 | BD6000 the Optima & BD5000 Birthing BedKNC · Traditional | Lic Care, Inc. | 11/24/1993SE |
| K915779 | Affinity Bed Model 3600 SeriesKNC · Traditional | Hill-Rom, Inc. | 02/24/1993SE |
| K903973 | Gardosi Birthing CushionKNC · Traditional | Graphic Controls Corp. | 09/27/1990SE |
| K884868 | Obstetrical Safety SystemKNC · Traditional | Buckman Co., Inc. | 03/01/1989SE |
| K870745 | Stryker Model 977 Birthing BedKNC · Traditional | Stryker Corp. | 02/27/1987SE |
| K864194 | Palmer Obstetric BraceKNC · Traditional | Ad-Tech Medical Instrument Corp | 01/14/1987SE |
| K862931 | Merivaara Obstetric Chair/Bed-Model 358KNC · Traditional | Global Medical Prods, Inc. | 08/07/1986SE |
| K861030 | Labor-Delivery Stretch/BedKNC · Traditional | Adel Medical , Ltd. | 04/23/1986SE |
| K852174 | Merivaara Obstetric Chair/Bed Model 358KNC · Traditional | Daun International, Inc. | 09/06/1985SE |
| K852171 | Cat. No. S-5300-E Birthing BedKNC · Traditional | Shampaine/Wilson | 08/30/1985SE |
| K844183 | Palmer Obstetic BraceKNC · Traditional | Mic Medical Corp. | 02/04/1985SE |
| K842962 | Lorraine DSL Labor & Delivery BedKNC · Traditional | Pulley-Kellam Co., Inc. | 09/25/1984SE |
| K833321 | Labor/Delivery/Recovery Bed LDR-600KNC · Traditional | Adel Medical , Ltd. | 11/14/1983SE |
| K831998 | Birthwell Birthing SystemKNC · Traditional | Qulab Co. | 09/12/1983SE |
| K831309 | Delivery 4 TableKNC · Traditional | Amsco Co. | 06/15/1983SE |
| K830873 | S & W Model AsoKNC · Traditional | S & W Enterprises, Inc. | 05/13/1983SE |
| K820175 | O.N.A.T.KNC · Traditional | Latex Medical Devices, Inc. | 01/29/1982SE |
| K812141 | Lic Obstetrical TableKNC · Traditional | Lada Intl., Inc. | 08/25/1981SE |
| K811902 | Century Birthing ChairKNC · Traditional | Century Manufacturing Co. | 08/25/1981SE |
| K801622 | Adel Medical Birthing Bed, Mod. LD-400KNC · Traditional | Adel Medical , Ltd. | 08/14/1980SE |
| K792568 | Obstetrical BedsKNC · Traditional | Ets Rene Marzet | 01/28/1980SE |
| K790950 | S/A 7800 Birth Support ChairKNC · Traditional | Schlosser Alberti Co. | 08/03/1979SE |
| K770437 | Table, ExaminationKNC · Traditional | I E Industries | 03/23/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1816-2025 Class II | Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433…There is a potential for improper crimps on the signal wires of the actuators which could result in a loss… | Baxter Healthcare Corporation | 05/06/2025Open, Classified |
| Z-2156-2021 Class II | Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an…Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could… | Hill-Rom, Inc. | 05/28/2021Terminated |
| Z-2750-2016 Class II | Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and… | Hill-Rom, Inc. | 07/15/2016Terminated |
| Z-2562-2014 Class II | Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing…The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could… | Hill-Rom, Inc. | 06/26/2014Terminated |
| Z-2082-2012 Class II | Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is…During review of our last braking system via that field corrective action, the system still did not meet our… | Hill-Rom, Inc. | 04/02/2012Terminated |
| Z-0584-2008 | Hill-Rom Affinity Four Birthing Bed, Model P3700B. Note: Not distributed in the U.S.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | Hill-Rom, Inc. | 11/21/2007Terminated |
| Z-0583-2008 | Hill-Rom Affinity Three Birthing Bed, Model P3700A.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | Hill-Rom, Inc. | 11/21/2007Terminated |
| Z-0582-2008 | Hill-Rom Affinity Two Birthing Bed, Model P3600.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | Hill-Rom, Inc. | 11/21/2007Terminated |
| Z-0581-2008 | Hill-Rom Affinity Birthing Bed, Model P3600.Hole/opening on the labor bar -- Amputation of a finger could result, if a finger is placed into the… | Hill-Rom, Inc. | 11/21/2007Terminated |