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
122521–122544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1991
VAS-CATH URETERAL STENTS CATHETER, MODIFICATION
K905505 · FAD
Vas-Cath, Inc.
Gastroenterology & Urology · 137d
Cleared Apr 09, 1991
MODEL FT40 TRANSONIC(TM) HEARING AID
K905516 · ESD
Sonovation, Inc. Dba Avr Sonovation
Ear, Nose, Throat · 123d
Cleared Apr 09, 1991
OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE
K910114 · GEX
Xintec Corporation
General & Plastic Surgery · 89d
Cleared Apr 09, 1991
USCI ILLUMEN-8 8F PTCA GUIDING CATHETER
K910154 · DOY
C.R. Bard, Inc.
Toxicology · 85d
Cleared Apr 09, 1991
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST
K910215 · FKP
Cd Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Apr 09, 1991
RENAFLO HDF 1350 HEMODIAFILTER
K910236 · KDI
Minntech Corp.
Gastroenterology & Urology · 81d
Cleared Apr 09, 1991
MICROTEST MULTI MICROBE MEDIUM
K910526 · JSM
Microtest
Microbiology · 61d
Cleared Apr 09, 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)
K910548 · LZO
Turnkey Intergration USA, Inc.
Orthopedic · 61d
Cleared Apr 09, 1991
MODEL 5866-46 SLEEVE KIT
K910568 · DTP
Medtronic Vascular
Cardiovascular · 57d
Cleared Apr 09, 1991
YSI PRECISION 4000 THERMOMETER
K910718 · FLL
Yellow Springs Instrument Co., Inc.
General Hospital · 48d
Cleared Apr 09, 1991
BCD ADVANCED
K910923 · DTR
Shiley, Inc.
Cardiovascular · 35d
Cleared Apr 09, 1991
MEDI-TECH BALLOON DILATATION CATHETER
K910995 · LIT
Boston Scientific Corp
Cardiovascular · 39d
Cleared Apr 09, 1991
OPTI-PLAST 5F PTA CATHETERS
K910996 · LIT
Vas-Cath, Inc.
Cardiovascular · 36d
Cleared Apr 09, 1991
TEGWIRE (TM)
K911203 · LIT
Boston Scientific Corp
Cardiovascular · 21d
Cleared Apr 08, 1991
MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR
K901540 · GXD
Radionics, Inc.
Neurology · 371d
Cleared Apr 08, 1991
DISPOSABLE FIBER OPTIC DELIVERY SYSTEM
K904420 · GEX
Fiber Delivery Concepts, Inc.
General & Plastic Surgery · 193d
Cleared Apr 08, 1991
CMS ONCOPROBE (TM)
K904421 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 193d
Cleared Apr 08, 1991
PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
K904848 · HET
Origin Medsystems, Inc.
Obstetrics & Gynecology · 164d
Cleared Apr 08, 1991
PROBE SURGEON'S GLOVES- STERILE
K905624 · KGO
Glove India Pvt. , Ltd.
General Hospital · 115d
Cleared Apr 08, 1991
STRATO LOW PROFILE PORT(LPS 1055)/MODIFICATION
K905846 · LJT
Strato Medical Corp.
General Hospital · 102d
Cleared Apr 08, 1991
LIFE PT VASC ACCESS PT W/DETACH CATH(LPS 6013)MODI
K905848 · LJT
Strato Medical Corp.
General Hospital · 102d
Cleared Apr 08, 1991
CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
K910020 · IZO
Capintec Instruments, Inc.
Radiology · 95d
Cleared Apr 08, 1991
SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65
K910051 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 91d
Cleared Apr 08, 1991
SCITECH BI-MANUAL ADAPTER CLIPS
K910088 · HQQ
Scitech Industries Partnership
Ophthalmic · 89d