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"
3289–3312 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 08, 2001
LIVESURE METHAMPHETAMINE SCREEN TESTS
K011610 · LAF
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 08, 2001
LIVESURE AMPHETAMINE SCREEN TEST
K011609 · DKZ
Pan Probe Biotech, Inc.
Toxicology · 14d
Cleared Jun 08, 2001
AIRLIFE HEPA FILTER
K011132 · CAH
Allegiance Healthcare Corp.
General Hospital · 56d
Cleared Jun 07, 2001
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN...
K010862 · KGO
Allegiance Healthcare Corp.
General Hospital · 77d
Cleared Jun 01, 2001
KOKO PEAK KP
K010009 · BZH
Pds Healthcare Products, Inc.
Anesthesiology · 150d
Cleared Jun 01, 2001
RESPIRATORY HUMIDIFIER, MODEL HC150
K003973 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 161d
Cleared May 31, 2001
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN...
K010961 · LYY
Ansell Healthcare Products, Inc.
General Hospital · 62d
Cleared May 31, 2001
CADHEALTH SYSTEM, MODEL CHP-001
K002514 · DRG
Caduceus Health Care , Ltd.
Cardiovascular · 289d
Cleared May 25, 2001
POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
K011186 · LYZ
Allegiance Healthcare Corp.
General Hospital · 37d
Cleared May 15, 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · FRN
Baxter Healthcare Corp
General Hospital · 78d
Cleared May 09, 2001
MP3HD BIG BOY, POWER WHEELCHAIR
K010380 · ITI
Merits Health Products., Inc.
Physical Medicine · 90d
Cleared May 02, 2001
VASCULAR ASSIST
K002186 · DPW
Huntleigh Healthcare, Inc.
Cardiovascular · 286d
Cleared May 01, 2001
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED)...
K002718 · LYY
Tillotson Healthcare Corp.
General Hospital · 243d
Cleared Apr 26, 2001
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K010955 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 27d
Cleared Apr 25, 2001
BABY DOPPLEX 3002 (BD3002)
K010894 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 30d
Cleared Apr 25, 2001
BABY DOPPLEX 3000 MK 2 (BD3000)
K010889 · HGM
Huntleigh Healthcare, Inc.
Obstetrics & Gynecology · 30d
Cleared Apr 17, 2001
LIVESURE COCAINE SCREEN TEST
K010967 · DIO
Pan Probe Biotech, Inc.
Toxicology · 15d
Cleared Apr 13, 2001
LIVESURE MORPHINE SCREEN TEST
K011011 · DOE
Pan Probe Biotech, Inc.
Toxicology · 9d
Cleared Apr 09, 2001
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K010909 · GAW
Tyco Healthcare Group LP
General & Plastic Surgery · 14d
Cleared Apr 05, 2001
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE...
K003350 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 161d
Cleared Apr 04, 2001
IVS TUNNELLER
K010035 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Apr 03, 2001
WHITE KNIGHT MASKS (21 MODELS, VARIOUS COLORS WITH AND WITHOUT FACE SHIELDS)
K001892 · FXX
White Knight Healthcare, Inc.
General Hospital · 286d
Cleared Apr 02, 2001
WHITE KNIGHT BLUE, GREEN FACE MASK, (4 MODELS)
K001997 · FXX
White Knight Healthcare, Inc.
General Hospital · 276d
Cleared Apr 02, 2001
WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)
K001893 · FXX
White Knight Healthcare, Inc.
General Hospital · 285d