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"
3457–3480 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jan 29, 1998
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
K973106 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 163d
Cleared Jan 28, 1998
PARACENTESIS CATHETER DEVICE
K974146 · GCB
Allegiance Healthcare Corp.
General & Plastic Surgery · 86d
Cleared Jan 26, 1998
HUNTLEIGH FP5000 SYSTEM MODEL FP5000
K965153 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 399d
Cleared Jan 22, 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS...
K974155 · DTN
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Jan 22, 1998
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
K974122 · MQX
Scientific Health Care
General Hospital · 83d
Cleared Jan 20, 1998
TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI...
K972614 · CAW
Healthdyne Technologies, Inc.
Anesthesiology · 190d
Cleared Jan 11, 1998
CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
K970663 · MSF
Baxter Healthcare Corp
Gastroenterology & Urology · 324d
Cleared Jan 06, 1998
POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM)
K974065 · LYY
Tillotson Healthcare Corp.
General Hospital · 71d
Cleared Dec 31, 1997
KENDALL CURITY IODOFORM PACKING STRIP
K973763 · EFQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Dec 18, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973913 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 65d
Cleared Dec 17, 1997
DENT-TEMP ACRYLIC
K972198 · EBG
Health-Dent Intl., Inc.
Dental · 189d