FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
4249–4272 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 21, 1991
FLO-GARD(R) 6200, 6300 & 8000
K913895 · FRN
Baxter Healthcare Corp
General Hospital · 52d
Cleared Oct 17, 1991
AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES
K914130 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 34d
Cleared Oct 17, 1991
AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER
K913832 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 52d
Cleared Oct 17, 1991
AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER
K913802 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 52d
Cleared Oct 17, 1991
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · JOL
Baxter Healthcare Corp
General Hospital · 240d
Cleared Oct 11, 1991
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506 · KKX
Baxter Healthcare Corp
General Hospital · 65d
Cleared Sep 27, 1991
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · KHO
Baxter Healthcare Corp
Chemistry · 73d
Cleared Sep 27, 1991
ENDOSCOPE SUTURE & CARRIER
K912973 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 81d
Cleared Sep 27, 1991
STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO
K912852 · JLW
Baxter Healthcare Corp
Chemistry · 91d
Cleared Sep 27, 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON
K911630 · FGE
Baxter Healthcare Corp
Gastroenterology & Urology · 169d
Cleared Sep 25, 1991
AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER
K913211 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 68d
Cleared Sep 25, 1991
SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER
K912920 · DTZ
3M Health Care, Ltd.
Cardiovascular · 84d
Cleared Sep 25, 1991
SARNS NON-FILTERED VENOUS RESERVOIR
K912915 · DTP
3M Health Care, Ltd.
Cardiovascular · 84d
Cleared Sep 25, 1991
LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE
K912839 · FBW
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Sep 23, 1991
3 PORT ADAPTER
K913627 · FPA
Baxter Healthcare Corp
General Hospital · 39d
Cleared Sep 19, 1991
SIME TRUFEEL
K913048 · LYY
Sime Health, Ltd.
General Hospital · 72d
Cleared Sep 19, 1991
AUTO SUTURE ENDOSCOPIC FASCIA STAPLER
K912097 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 129d
Cleared Sep 16, 1991
STERILE SURGICAL GOWN PACK
K911131 · KKX
Central Georgia Ancillary Health Systems
General Hospital · 186d
Cleared Sep 13, 1991
DENTAL NEEDLE PROTECTIVE SYSTEM
K910475 · DZM
Health Technology Systems, Inc.
Dental · 219d
Cleared Sep 11, 1991
TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE
K913207 · KGO
Baxter Healthcare Corp
General Hospital · 54d
Cleared Sep 11, 1991
HYPER-K HEAT SYSTEM
K912722 · ILO
Baxter Healthcare Corp
Physical Medicine · 85d
Cleared Sep 11, 1991
VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE
K912141 · FPA
Baxter Healthcare Corp
General Hospital · 120d
Cleared Sep 10, 1991
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
K912679 · GJT
Baxter Healthcare Corp
Hematology · 84d
Cleared Sep 10, 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K905860 · JXG
Baxter Healthcare Corp
Neurology · 263d