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"
3625–3648 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 15, 1996
PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
K961077 · BWF
Healthscan Products, Inc.
Anesthesiology · 119d
Cleared Jul 10, 1996
SURGICAL DYNAMICS POP RIVET
K961585 · JDR
United States Surgical, A Division of...
Orthopedic · 77d
Cleared Jul 10, 1996
SUTURE ANCHOR
K961578 · JDR
United States Surgical, A Division of...
Orthopedic · 77d
Cleared Jul 08, 1996
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC...
K961703 · FRN
Baxter Healthcare Corp
General Hospital · 67d
Cleared Jun 26, 1996
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK...
K961495 · FPA
Baxter Healthcare Corp
General Hospital · 69d
Cleared Jun 26, 1996
THERMACYL BLOOD/FLUID WARMER
K953741 · BSB
Baxter Healthcare Corp
Hematology · 321d
Cleared Jun 25, 1996
HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM
K955853 · JOW
Healthcare Service and Supply
Cardiovascular · 187d
Cleared Jun 21, 1996
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
K961225 · FPA
Baxter Healthcare Corp
General Hospital · 84d
Cleared Jun 07, 1996
KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
K960981 · LMB
Kodak Health Imaging Systems, Inc.
Radiology · 88d
Cleared Jun 06, 1996
BAXTER SODIUM ACETATE INFANT HEEL WARMER
K961154 · MPO
Baxter Healthcare Corp
Physical Medicine · 76d
Cleared Jun 04, 1996
SAMS 8000 CARDIOPLEGIA MONITOR
K960916 · DSJ
3M Health Care, Sarns
Cardiovascular · 90d
Cleared May 30, 1996
KENDALL BLUNT TUOHY EPIDURAL NEEDLE
K954706 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 231d
Cleared May 28, 1996
JAZZY
K945936 · ITI
Pride Health Care, Inc.
Physical Medicine · 540d
Cleared May 23, 1996
MANAN INTRODUCER SHEALTH/NEEDLE
K961216 · FGE
Manan Medical Products, Inc.
Gastroenterology & Urology · 56d
Cleared May 23, 1996
CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION)
K953205 · KOI
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 359d
Cleared May 22, 1996
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
K960955 · GBX
Baxter Healthcare Corp
General & Plastic Surgery · 72d
Cleared May 14, 1996
TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
K960787 · LJH
Baxter Healthcare Corp
Gastroenterology & Urology · 78d
Cleared May 08, 1996
M.I.C.
K950967 · JOW
V.V.T. Healthcare Technologies, Inc.
Cardiovascular · 447d
Cleared May 01, 1996
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · FXX
3M Company
General Hospital · 159d
Cleared Apr 26, 1996
MEDICATOR AEROSOL DRUG DELIVERY SYSTEM
K960397 · CAF
Healthline Medical
Anesthesiology · 88d
Cleared Apr 25, 1996
FLUID REISISTANT EYESHIELD MASK
K955557 · FXX
American Threshold Healthcare
General Hospital · 142d
Cleared Apr 25, 1996
FLUID RESISTANT MASK
K955556 · FXX
American Threshold Healthcare
General Hospital · 142d
Cleared Apr 22, 1996
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
K952879 · KFM
Baxter Healthcare Corp
Cardiovascular · 304d
Cleared Apr 19, 1996
SARNS 9000 UNIVERSAL ROLLER PUMP
K953904 · DWB
3M Health Care, Ltd.
Cardiovascular · 245d