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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
116521–116544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1992
LASER-6
K921096 · GEX
Laser Endo Technic
General & Plastic Surgery · 141d
Cleared Jul 28, 1992
ACS APCT REAGENT
K921118 · GFO
Analytical Control Systems, Inc.
Hematology · 141d
Cleared Jul 28, 1992
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K921180 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 140d
Cleared Jul 28, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302 · JHI
Vitek Systems, Inc.
Chemistry · 131d
Cleared Jul 28, 1992
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
K921421 · LHL
Pro-Lab, Inc.
Microbiology · 126d
Cleared Jul 28, 1992
SYNELISA TPO ANTIBODIES
K921787 · JNL
Elias U.S.A., Inc.
Immunology · 105d
Cleared Jul 28, 1992
MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL
K922000 · LNH
Mri Devices Corp.
Radiology · 90d
Cleared Jul 28, 1992
SPECTACLE FRAMES
K922001 · HQZ
Otego Optical, Inc.
Ophthalmic · 90d
Cleared Jul 28, 1992
MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM
K922084 · GKZ
Gen Trak, Inc.
Hematology · 85d
Cleared Jul 28, 1992
MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM
K922085 · GKZ
Gen Trak, Inc.
Hematology · 85d
Cleared Jul 28, 1992
WAKO AUTOKIT RF
K922151 · DHR
Wako Chemicals USA, Inc.
Immunology · 82d
Cleared Jul 28, 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922168 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 81d
Cleared Jul 28, 1992
LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)
K922563 · LDD
Raco Products Co.
Cardiovascular · 57d
Cleared Jul 28, 1992
LORACARBEF 30MCG DISK
K922791 · JTN
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Jul 28, 1992
CEFZIL
K922793 · JTN
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Jul 28, 1992
ENOXACIN
K922794 · JTN
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Jul 28, 1992
OLYMPUS ALANINE AMINOTRANSFERASE REAGENT
K922884 · CKA
Olympus Corp.
Chemistry · 42d
Cleared Jul 28, 1992
OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT
K922885 · CIT
Olympus Corp.
Chemistry · 42d
Cleared Jul 27, 1992
PEAK FLOW MONITOR
K915059 · BZH
Spirometrics, Inc.
Anesthesiology · 262d
Cleared Jul 27, 1992
CATHETER TWO STAGE VENOUS RETURN
K915268 · DWF
Dlp, Inc.
Cardiovascular · 245d
Cleared Jul 27, 1992
HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS
K920222 · LJO
Akers Research Corp.
Microbiology · 193d
Cleared Jul 27, 1992
BIVONA TRACHEAL T-TUBE STENT
K920604 · BTO
Bivona Medical Technologies
Anesthesiology · 167d
Cleared Jul 27, 1992
HEMO-BAND
K920614 · KOC
Innovations IN Access, Inc.
Gastroenterology & Urology · 167d
Cleared Jul 27, 1992
ACE 100 DEGREES TUBULAR PLATE
K920738 · HRS
Ace Orthopedic Manufacturing Co.
Orthopedic · 159d