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

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175,820 results
126337–126360 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1990
LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE
K896850 · LZO
Lima Intl. Corp.
Orthopedic · 182d
Cleared Jun 05, 1990
IRRIGATION AND SUCTION APPARATUS
K900430 · JCX
Acorn Group, Inc.
General & Plastic Surgery · 126d
Cleared Jun 05, 1990
LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG.
K901128 · GEX
Lasercomp
General & Plastic Surgery · 85d
Cleared Jun 05, 1990
EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS
K901204 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 83d
Cleared Jun 05, 1990
L.M.S. SELF-DETACHABLE BROACH WITH STOP
K901273 · HTY
Med-Tek Corp.
Orthopedic · 78d
Cleared Jun 05, 1990
HORIZON SURGICAL LIGATING AND MARKING CLIP
K901303 · DSS
Horizon Surgical, Inc.
Cardiovascular · 77d
Cleared Jun 05, 1990
GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II
K901369 · KGN
Sterling Drug, Inc.
General & Plastic Surgery · 74d
Cleared Jun 05, 1990
SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE
K901429 · OCY
Telemed Systems, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 04, 1990
CONDOM (RUBBER) CONTRACEPTIVE
K901416 · HIS
Aladan Corp.
Obstetrics & Gynecology · 70d
Cleared Jun 01, 1990
CT-1000A SYSTEM
K896779 · FLL
Bio-Monitor, Inc.
General Hospital · 182d
Cleared Jun 01, 1990
ATRAUCLIP (TANTALUM HEMOSTATIC CLIP)
K896998 · MCH
S.P.K. Technology, Inc.
General & Plastic Surgery · 171d
Cleared Jun 01, 1990
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
K900488 · EJF
American Orthodontics
Dental · 122d
Cleared Jun 01, 1990
LATEX EXAMINATION GLOVES
K900980 · LYY
Sinochem (Usa), Inc.
General Hospital · 91d
Cleared Jun 01, 1990
ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
K901084 · KXO
Healthdyne Cardiovascular, Inc.
Obstetrics & Gynecology · 86d
Cleared Jun 01, 1990
ENTERA-FLO FEEDING TUBE
K901130 · KNT
Fresenius Pharma
Gastroenterology & Urology · 81d
Cleared Jun 01, 1990
RIGID URETEROSCOPE
K901214 · FGB
Applied Urology, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 01, 1990
SPEC(TM) EXTRACTION CARTRIDGE
K901694 · DKE
Toxi-Lab, Inc.
Toxicology · 52d
Cleared Jun 01, 1990
600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET
K901753 · KNT
Chartermed, Inc.
Gastroenterology & Urology · 46d
Cleared Jun 01, 1990
URESIL TRU-CLOSE DRAINAGE BAG
K901844 · EXF
Uresil Corp.
Gastroenterology & Urology · 38d
Cleared Jun 01, 1990
VIVAALLOY HR (AMALGAM)
K901911 · EJJ
Ivoclar North America, Inc.
Dental · 36d
Cleared Jun 01, 1990
CP-3 DENTAL POLISHING MATERIAL
K901973 · EJR
Gresco Products, Inc.
Dental · 31d
Cleared Jun 01, 1990
FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR
K901996 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 01, 1990
PATHODX PYR KIT
K902037 · JTO
Diagnostic Products Corp.
Microbiology · 28d
Cleared Jun 01, 1990
NA LATEX MYOGLOBIN TEST
K902154 · DDR
Behring Diagnostics, Inc.
Immunology · 17d