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
113161–113184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 1993
CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT
K924142 · KWP
Codman & Shurtleff, Inc.
Orthopedic · 302d
Cleared Jun 15, 1993
BOOST, MICE, GAMESYS.
K924416 · KQX
Penny and Giles Biometrics , Ltd.
Neurology · 288d
Cleared Jun 15, 1993
EXACTECH FEMORAL STEM
K925201 · JDI
Exactech, Inc.
Orthopedic · 242d
Cleared Jun 15, 1993
PRO-STEP PT HCG
K925303 · JHI
Disease Detection International, Inc.
Chemistry · 237d
Cleared Jun 15, 1993
OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS
K925883 · JDJ
Osteonics Corp.
Orthopedic · 208d
Cleared Jun 15, 1993
BION MUMPS-G ANTIBODY TEST SYSTEM
K926066 · CAR
Bion Ent., Ltd.
Microbiology · 196d
Cleared Jun 15, 1993
BECKMAN ANTI-STREPTOLYSIN O KIT
K926236 · GTQ
Beckman Instruments, Inc.
Microbiology · 186d
Cleared Jun 15, 1993
ACCESS(R) THYROXINE ASSAY
K926475 · KLI
Bio-Rad Laboratories, Inc.
Chemistry · 168d
Cleared Jun 15, 1993
COAT-A-COUNT INTACT PTH IRMA
K930008 · CEW
Diagnostic Products Corp.
Chemistry · 162d
Cleared Jun 15, 1993
IMX(R) STAT CK-MB
K931172 · JHY
Abbott Laboratories
Chemistry · 99d
Cleared Jun 15, 1993
KING DIAGNOSTICS CK REAGENT
K931326 · CGS
King Diagnostics, Inc.
Chemistry · 91d
Cleared Jun 15, 1993
ANALYZER: STAT PROFILE PLUS 10 ANALYZER
K931373 · JJY
Nova Biomedical Corp.
Chemistry · 89d
Cleared Jun 15, 1993
AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
K931374 · MLA
Microprobe Corp.
Microbiology · 89d
Cleared Jun 15, 1993
ZINC PVA
K931383 · LIO
Remel Co.
Microbiology · 89d
Cleared Jun 15, 1993
EMIT(R) D.A.U. BARBITURATE ASSAY
K931535 · DIS
Syva Co.
Toxicology · 78d
Cleared Jun 15, 1993
CHEMSTRIP URINE ANALYZER
K931602 · KQO
Boehringer Mannheim Corp.
Chemistry · 75d
Cleared Jun 15, 1993
PARA-PAK PLUS
K931770 · LIO
Meridian Diagnostics, Inc.
Microbiology · 67d
Cleared Jun 15, 1993
REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK
K931799 · JTN
Remel Co.
Microbiology · 64d
Cleared Jun 15, 1993
NINHYDRIN REAGENT
K931862 · JTO
Hardy Diagnostics
Microbiology · 62d
Cleared Jun 15, 1993
USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200
K932318 · DJG
U.S. Drug Testing, Inc.
Toxicology · 35d
Cleared Jun 14, 1993
TOTAL HIP PROTHESIS FEMORAL COMPONENT
K923734 · LZO
Intermedics Orthopedics
Orthopedic · 322d
Cleared Jun 14, 1993
INTERSPEC APOGEE CLA
K924231 · IYO
Interspec, Inc.
Radiology · 297d
Cleared Jun 14, 1993
MICRO MASKER
K924991 · KLW
Associated Hearing Instruments
Ear, Nose, Throat · 256d
Cleared Jun 14, 1993
PICTURE ARCHIVING AND COMMUNICATION SYSTEMS
K925965 · IYO
Advanced Light Imaging Technologies ,...
Radiology · 201d