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"
3289–3312 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 23, 2000
KLINIDRAPE SURGICAL DRAPES
K000906 · KKX
Molnlycke Health Care, Inc.
General Hospital · 94d
Cleared Jun 13, 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC...
K992532 · FOZ
Baxter Healthcare Corp
General Hospital · 320d
Cleared Jun 13, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
K001485 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 32d
Cleared Jun 13, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100...
K001475 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 33d
Cleared Jun 12, 2000
MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
K001252 · IOR
Maxhealth Corp.
Physical Medicine · 54d
Cleared Jun 09, 2000
MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
K000377 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 123d
Cleared Jun 08, 2000
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
K000813 · LZA
Allegiance Healthcare Coporation
General Hospital · 87d
Cleared Jun 02, 2000
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared May 18, 2000
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
K001098 · FMI
Pro. Duct Health, Inc.
Pathology · 44d
Cleared May 16, 2000
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS...
K000303 · JOW
Healthcare Service and Supply
Cardiovascular · 105d
Cleared May 09, 2000
POWDER FREE STERILE LATEX EXAMINATION GLOVES
K001141 · LYY
Allegiance Healthcare Corp.
General Hospital · 29d
Cleared May 03, 2000
SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF...
K000745 · LYY
Tillotson Healthcare Corp.
General Hospital · 56d
Cleared Apr 28, 2000
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
K993756 · KGO
Pamitex Industries Sdn Bhd
General Hospital · 175d
Cleared Apr 21, 2000
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
K993871 · FRG
Allegiance Healthcare Corp.
General Hospital · 158d
Cleared Apr 21, 2000
MODIFICATION TO CONVERTORS SURGICAL GOWNS
K001189 · FYA
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Apr 10, 2000
PRO.DUCT CATHETER, MODEL CTH03
K000135 · KNW
Pro. Duct Health, Inc.
Gastroenterology & Urology · 83d
Cleared Apr 07, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
K000828 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 24d
Cleared Mar 30, 2000
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
K000697 · BZE
Allegiance Healthcare Corp.
Anesthesiology · 29d
Cleared Mar 30, 2000
MONOFILAMENT BIOSYN SUTURE
K000037 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 84d
Cleared Mar 29, 2000
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
K993201 · KGO
Pamitex Industries Sdn Bhd
General Hospital · 187d
Cleared Mar 17, 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · KKX
Allegiance Healthcare Corp.
General Hospital · 38d
Cleared Mar 10, 2000
SPIRAL RADIUS RODDING SYSTEM
K000009 · KWQ
United States Surgical, A Division of...
Orthopedic · 67d
Cleared Mar 08, 2000
LUER ACCESS UNIVERSAL VIAL ADAPTER
K000657 · FMI
Baxter Healthcare Corp
General Hospital · 9d
Cleared Feb 18, 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · FYA
Allegiance Healthcare Corp.
General Hospital · 64d