FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,281 results for "health"
3433–3456 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 25, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
K992165 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 58d
Cleared Aug 25, 1999
BIOSHIELD EXPRESS STERILIZATION WRAP
K983719 · FRG
Allegiance Healthcare Corp.
General Hospital · 308d
Cleared Aug 23, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
K992299 · LZA
Pamitex Industries Sdn Bhd
General Hospital · 46d
Cleared Aug 12, 1999
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514 · FYA
Allegiance Healthcare Corp.
General Hospital · 15d
Cleared Aug 09, 1999
ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
K992428 · LYY
Tillotson Healthcare Corp.
General Hospital · 19d
Cleared Jul 26, 1999
LUER ACCESS INJECTION SITE
K984060 · FPA
Baxter Healthcare Corp
General Hospital · 255d
Cleared Jul 22, 1999
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
K992207 · DIO
Syntron Bioresearch, Inc.
Toxicology · 22d
Cleared Jul 13, 1999
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
K991992 · KGO
Allegiance Healthcare Corp.
General Hospital · 29d
Cleared Jul 12, 1999
BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
K991300 · BWF
Dhd Healthcare Corp.
Anesthesiology · 87d
Cleared Jun 25, 1999
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
K991928 · GCJ
Allegiance Healthcare Corp.
General & Plastic Surgery · 17d
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (PRE POWDERED)
K991690 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (POWDER FREE)
K991689 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d
Cleared Jun 23, 1999
DEXIDE BIPOLAR FORCEPS II ** DEVICE
K991859 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 22d
Cleared Jun 23, 1999
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K991304 · LZA
M.R.G. Industries Sdn. Bhd.
General Hospital · 68d
Cleared Jun 21, 1999
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
K991305 · LYY
M.R.G. Industries Sdn. Bhd.
General Hospital · 66d
Cleared Jun 18, 1999
RENAL LINK
K990953 · KPF
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Jun 11, 1999
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1
K991831 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 14d
Cleared Jun 11, 1999
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
K991215 · EFQ
Symtex Healthcare Corp.
General & Plastic Surgery · 63d
Cleared Jun 04, 1999
AUTO SUTURE ABBI SYSTEM
K983296 · KNW
United States Surgical, A Division of...
Gastroenterology & Urology · 256d
Cleared May 28, 1999
HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
K991640 · LZA
M.R.G. Industries Berhad
General Hospital · 16d
Cleared May 18, 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 11d
Cleared May 13, 1999
AIRLIFE BUBBLE HUMIDIFER, MODEL 002003 AND 002006
K991484 · BTT
Allegiance Healthcare Corp.
Anesthesiology · 15d
Cleared Apr 21, 1999
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
K982413 · KDI
Gambro Healthcare
Gastroenterology & Urology · 282d
Cleared Apr 16, 1999
CONVERTORS SURGICAL GOWNS
K991034 · FYA
Allegiance Healthcare Corp.
General Hospital · 18d