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"
3337–3360 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 30, 2000
CRANIOCAP
K000861 · MVA
Gillette Children'S Specialty Healthcare
Neurology · 227d
Cleared Oct 26, 2000
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
K994390 · MSF
Gambro Healthcare
Gastroenterology & Urology · 303d
Cleared Oct 23, 2000
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K000838 · LYY
P.T. Healthcare Glovindo
General Hospital · 223d
Cleared Oct 19, 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · FPA
Baxter Healthcare Corp
General Hospital · 3d
Cleared Oct 13, 2000
HL168B
K002882 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Sep 25, 2000
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
K002414 · LBI
Fisher &Paykel Healthcare , Ltd.
General Hospital · 49d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664 · DXG
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Sep 19, 2000
BABY DOPPLEX 4002-TWINS, MODEL BD4002
K001882 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 18, 2000
HL168T
K002750 · DXN
Health & Life Co., Ltd.
Cardiovascular · 13d
Cleared Sep 18, 2000
6060 MULTI-THERAPY PUMP, MODEL 2M9832
K002679 · FRN
Baxter Healthcare Corp
General Hospital · 21d
Cleared Sep 11, 2000
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · MEA
Baxter Healthcare Corp
General Hospital · 10d
Cleared Sep 05, 2000
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K002380 · FRN
Baxter Healthcare Corp
General Hospital · 32d
Cleared Sep 01, 2000
EQUIPMENT DRAPES
K002508 · KKX
Allegiance Healthcare Corp.
General Hospital · 17d
Cleared Aug 25, 2000
KARMAN WHEELCHAIR
K002202 · IOR
Karman Healthcare, Inc.
Physical Medicine · 36d
Cleared Aug 25, 2000
KARMAN WHEELCHAIR
K002167 · IOR
Karman Healthcare, Inc.
Physical Medicine · 38d
Cleared Aug 16, 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · HRX
United States Surgical, A Division of...
Orthopedic · 44d
Cleared Aug 15, 2000
SURGICAL DRAPES
K002419 · KKX
Allegiance Healthcare Coporation
General Hospital · 7d
Cleared Aug 11, 2000
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K993875 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 270d
Cleared Aug 04, 2000
ALLEGIANCE GENESIS CONTAINER SYSTEM
K983299 · FRG
Allegiance Healthcare Corp.
General Hospital · 683d
Cleared Aug 04, 2000
ENRAF-NONIUS SONOPULS 190 SYSTEM
K000084 · IMI
Henley Healthcare, Inc.
Physical Medicine · 205d
Cleared Jul 31, 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
K001883 · HIS
Ansell Healthcare, Inc.
Obstetrics & Gynecology · 40d
Cleared Jul 28, 2000
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP...
K002211 · FRN
Baxter Healthcare Corp
General Hospital · 7d
Cleared Jul 27, 2000
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS...
K001739 · LYY
Allegiance Healthcare Corp.
General Hospital · 49d
Cleared Jul 18, 2000
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 71d