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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
69001–69024 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2004
TESCERA U-BAR AND BARRELS
K033472 · EBI
Bisco, Inc.
Dental · 73d
Cleared Jan 15, 2004
KLS-MARTIN ORTHO ANCHORAGE SYSTEM
K033483 · DZE
KLS-Martin L.P.
Dental · 72d
Cleared Jan 15, 2004
EASI ECG ALGORITHM
K033513 · DRW
Philips Medical Systems
Cardiovascular · 70d
Cleared Jan 15, 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · HWC
Acumed, LLC
Orthopedic · 56d
Cleared Jan 15, 2004
FORCE FIBER
K033654 · GAT
Teleflex Medical
General & Plastic Surgery · 55d
Cleared Jan 15, 2004
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · KOJ
Sirona Dental Systems GmbH
Dental · 52d
Cleared Jan 15, 2004
CONCEPT HP ADD-ON
K033773 · EBF
Ivoclar Vivadent, AG
Dental · 43d
Cleared Jan 15, 2004
MODIFICATION TO SERAQUEST VCA IGM
K033780 · LJN
Quest Intl., Inc.
Microbiology · 42d
Cleared Jan 15, 2004
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
K033815 · NPM
Geistlich-Pharma
Dental · 37d
Cleared Jan 15, 2004
ADVANCE DOUBLE HIGH INSERT
K033890 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Jan 15, 2004
ARTHOSCOPY PUMP A115
K033927 · HRX
W.O.M. World of Medicine AG
Orthopedic · 28d
Cleared Jan 15, 2004
SOLAR 9500 INFORMATION MONITOR
K033964 · MHX
Ge Medical Systems Information...
Cardiovascular · 24d
Cleared Jan 15, 2004
GAMMA3 NAIL SYSTEM
K034002 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Jan 15, 2004
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
K034023 · FLL
Microlife Intellectual Property GmbH
General Hospital · 17d
Cleared Jan 15, 2004
MODIFICATION TO X-PORT DUO PORT
K034065 · LJT
C.R. Bard, Inc.
General Hospital · 17d
Cleared Jan 14, 2004
INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
K030739 · FRN
Infusion Dynamics, Inc.
General Hospital · 310d
Cleared Jan 14, 2004
NASAL-AIR CRITICAL CARE
K031896 · MNS
Innomed Technologies
Anesthesiology · 209d
Cleared Jan 14, 2004
MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND...
K031908 · CAF
Med2000 S.R.L.
Anesthesiology · 208d
Cleared Jan 14, 2004
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE...
K032245 · GAT
Arthrex, Inc.
General & Plastic Surgery · 176d
Cleared Jan 14, 2004
AEROCHAMBER MAX VALVED HOLDING CHAMBER
K032972 · CAF
Trudell Medical Intl.
Anesthesiology · 112d
Cleared Jan 14, 2004
ORACLE ORAL MASK, MODEL HC451A
K033087 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 107d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE
K033557 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Jan 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64...
K033560 · LON
Becton, Dickinson & CO
Microbiology · 63d
Cleared Jan 14, 2004
MODIFICATION TO V-CATH POLY PICC
K033853 · FOZ
Hdc Corp.
General Hospital · 34d