FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123913–123936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1990
CLUB FOOT CPM MACHINE
K903851 · BXB
Smith & Nephew Richards, Inc.
Physical Medicine · 59d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 10.5 FR 40CC
K903867 · DSP
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL
K903892 · DSP
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL
K903893 · DSP
Datascope Corp.
Cardiovascular · 58d
Cleared Oct 19, 1990
URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION
K903994 · FGF
Applied Urology, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 19, 1990
DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL
K904018 · DSP
Datascope Corp.
Cardiovascular · 50d
Cleared Oct 19, 1990
CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES
K904162 · GEX
Norco, Inc.
General & Plastic Surgery · 38d
Cleared Oct 19, 1990
FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM
K904340 · JDR
Neoligaments, Ltd.
Orthopedic · 29d
Cleared Oct 19, 1990
CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR
K904366 · HQF
Douglas James Donaldson Compliance...
Ophthalmic · 25d
Cleared Oct 19, 1990
LATEX EXAMINATION GLOVES(MFG: MODLOOK INDUSTRIES)
K904641 · LYY
Predex Co. , Ltd.
General Hospital · 8d
Cleared Oct 19, 1990
VINYL EXAMINATION GLOVES(MFG:KAO YING INDUSTRIAL)
K904642 · LYZ
Predex Co. , Ltd.
General Hospital · 8d
Cleared Oct 17, 1990
AUTO SUTURE(R) ENDOSCOPIC SCISSORS
K903206 · HET
United States Surgical, A Division of...
Obstetrics & Gynecology · 89d
Cleared Oct 17, 1990
MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP
K903494 · DXT
Life-Tech Intl., Inc.
Gastroenterology & Urology · 75d
Cleared Oct 17, 1990
ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N
K903598 · HET
Dixon Medical, Inc.
Obstetrics & Gynecology · 70d
Cleared Oct 17, 1990
ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N
K903599 · HET
Dixon Medical, Inc.
Obstetrics & Gynecology · 70d
Cleared Oct 17, 1990
ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N
K903600 · HET
Dixon Medical, Inc.
Obstetrics & Gynecology · 70d
Cleared Oct 17, 1990
KERATOME
K903912 · HNO
Micro Precision Instrument Co.
Ophthalmic · 54d
Cleared Oct 17, 1990
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM
K904077 · LJT
Med Institute, Inc.
General Hospital · 42d
Cleared Oct 17, 1990
PCA (R) TIBIAL BONE WEDGES
K904170 · JWH
Howmedica Corp.
Orthopedic · 36d
Cleared Oct 17, 1990
INSET PATELLAR COMPONENT
K904300 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 28d
Cleared Oct 17, 1990
FOCUS COBALT CHROMIUM TOTAL HIP
K904351 · JDI
Depuy, Inc.
Orthopedic · 23d
Cleared Oct 17, 1990
SAFE-T-STIK
K904382 · FMF
Xikon Technology
General Hospital · 21d
Cleared Oct 17, 1990
PATIENT EXAMINATION GLOVES
K904443 · LYY
Pisak Enterprise Co., Ltd.
General Hospital · 19d
Cleared Oct 17, 1990
SONY CINE VIDEO SYSTEM SME-3500
K904447 · IZI
Sony Medical Electronics Co.
Radiology · 19d