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"
3529–3552 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 15, 1998
3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
K980732 · DRY
3M Healthcare
Cardiovascular · 79d
Cleared May 11, 1998
SOFSILK SUTURE
K981128 · GAP
United States Surgical, A Division of...
General & Plastic Surgery · 42d
Cleared Apr 25, 1998
AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER
K972911 · GAT
United States Surgical, A Division of...
General & Plastic Surgery · 261d
Cleared Apr 22, 1998
DUAL LUER LOCK CAP
K981318 · FPA
Baxter Healthcare Corp
General Hospital · 12d
Cleared Apr 21, 1998
FERNO HEALTHCARE RECLINE-A-BATH 2
K980033 · ILJ
Ferno-Washington, Inc.
Physical Medicine · 106d
Cleared Apr 09, 1998
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
K980617 · GDW
Urohealth Systems, Inc.
General & Plastic Surgery · 76d
Cleared Apr 01, 1998
HTL MALE CONDOM
K980019 · HIS
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 89d
Cleared Mar 27, 1998
SOFSILK SUTURE
K980124 · GAP
United States Surgical, A Division of...
General & Plastic Surgery · 72d
Cleared Mar 19, 1998
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
K973532 · CAF
Dhd Diemolding Healthcare Div.
Anesthesiology · 182d
Cleared Mar 13, 1998
LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING
K973664 · LYY
Evergrade Healthcare Products Sdn Bhd
General Hospital · 169d
Cleared Mar 11, 1998
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)
K970662 · MSF
Baxter Healthcare Corp
Gastroenterology & Urology · 383d
Cleared Mar 11, 1998
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970653 · MSF
Baxter Healthcare Corp
Gastroenterology & Urology · 383d
Cleared Mar 10, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734 · MNH
United States Surgical, A Division of...
Orthopedic · 82d
Cleared Feb 13, 1998
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS...
K974318 · JOW
Healthcare Service and Supply
Cardiovascular · 88d
Cleared Feb 10, 1998
STERILE SALINE FOR CATHETER CARE
K974397 · JOL
Baxter Healthcare Corp
General Hospital · 81d
Cleared Feb 10, 1998
LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANT
K974323 · HIS
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 84d
Cleared Feb 09, 1998
LATEX (POWDER FREE) LOW PROTEIN
K974853 · LYY
P.T. Healthcare Glovindo
General Hospital · 42d
Cleared Feb 09, 1998
LATEX CONDOMS (NATURAL COLOUR)
K974326 · LTZ
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 83d
Cleared Feb 09, 1998
LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANT
K974324 · LTZ
Reddy Medtech Health Products , Ltd.
Obstetrics & Gynecology · 83d
Cleared Feb 04, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974213 · MNH
United States Surgical, A Division of...
Orthopedic · 86d
Cleared Feb 04, 1998
FLEXIBLE TIP DIGITAL THERMOMETER
K974195 · FLL
K-Jump Health Co., Ltd.
General Hospital · 89d
Cleared Feb 03, 1998
3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL...
K974553 · GEI
3M Healthcare
General & Plastic Surgery · 78d
Cleared Jan 30, 1998
3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M...
K974279 · GEI
3M Healthcare
General & Plastic Surgery · 77d
Cleared Jan 29, 1998
SURGEON'S GLOVES
K974356 · KGO
American Health Products, Inc.
General Hospital · 71d