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"
3217–3240 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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 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
Cleared Mar 19, 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747 · DBA
Baxter Healthcare Corp
Immunology · 105d
Cleared Mar 19, 2001
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
K002665 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 206d
Cleared Mar 12, 2001
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K010548 · HAW
Radionics, A Division of Tyco...
Neurology · 14d
Cleared Feb 28, 2001
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
K010077 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 49d
Cleared Feb 23, 2001
100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
K003749 · FYC
Banta Healthcare
General Hospital · 81d
Cleared Feb 21, 2001
MEDRELIEF
K003507 · GZJ
Healthonics, Inc.
Neurology · 100d
Cleared Feb 15, 2001
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · LZC
Allegiance Healthcare Corp.
General Hospital · 23d
Cleared Feb 14, 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 208d
Cleared Feb 06, 2001
SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT...
K004048 · LYY
Tillotson Healthcare Corp.
General Hospital · 39d