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
142921–142944 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 1986
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
K860679 · DCN
Orion Corp.
Immunology · 160d
Cleared Aug 04, 1986
FORETEL, COLOR OVULATION TEST
K860828 · CEP
Nms Pharmaceuticals, Inc.
Chemistry · 152d
Cleared Aug 04, 1986
MIKROS, MIKROS VS-1, PULSE GENERATOR
K860922 · DXY
Biotronik Sales, Inc.
Cardiovascular · 146d
Cleared Aug 04, 1986
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR
K861368 · JOQ
Medtronic Vascular
Cardiovascular · 115d
Cleared Aug 04, 1986
PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST
K861974 · LNJ
Perceptive Systems, Inc.
Pathology · 75d
Cleared Aug 04, 1986
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL
K862185 · JJY
Bio-Rad
Chemistry · 56d
Cleared Aug 04, 1986
TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER
K862206 · JJJ
Micromedic Systems
Chemistry · 55d
Cleared Aug 04, 1986
AMIKACIN KIT (FPIA)
K862248 · LGJ
Windsor Laboratories, Inc.
Toxicology · 53d
Cleared Aug 04, 1986
GAS-TRAK
K862278 · JJY
United Diagnostics, Inc.
Chemistry · 49d
Cleared Aug 04, 1986
UTAK-STABBS TOXICOLOGY CONTROL
K862420 · JJY
Utak Laboratories, Inc.
Toxicology · 40d
Cleared Aug 04, 1986
PARAMAX LIPASE REAGENT
K862440 · CET
American Dade
Chemistry · 39d
Cleared Aug 04, 1986
CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY
K862542 · DII
Supelco, Inc.
Toxicology · 32d
Cleared Aug 04, 1986
HOLLISTER WOUND CARE BARRIER
K862572 · FRO
Hollister, Inc.
General & Plastic Surgery · 28d
Cleared Aug 04, 1986
CHEMVARION(TM)
K862586 · JJY
G.B.F. Industries, Inc.
Chemistry · 28d
Cleared Aug 04, 1986
CHEMTROL(TM)
K862587 · JJY
G.B.F. Industries, Inc.
Chemistry · 28d
Cleared Aug 04, 1986
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT
K862607 · LIO
Boots-Celltech Diagnostics, Inc.
Microbiology · 27d
Cleared Aug 04, 1986
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95
K862703 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Aug 04, 1986
USA ASPIRATOR
K862751 · BTA
U. S. A. Medical Corp.
General & Plastic Surgery · 13d
Cleared Aug 04, 1986
VACUTAINER BRAND AGAR SLANT
K862761 · KZI
Bd Becton Dickinson Vacutainer...
Microbiology · 13d
Cleared Aug 04, 1986
TRU-KINETICS (TM)
K862780 · IKK
Tru-Trac
Physical Medicine · 28d
Cleared Aug 01, 1986
SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC
K852331 · IZI
Scholten Surgical Instruments, Inc.
Radiology · 427d
Cleared Aug 01, 1986
MICROCOR E.C.G. MONITOR WITH A.C. ADAPTER
K861281 · DPS
Microcor, Inc.
Cardiovascular · 116d
Cleared Aug 01, 1986
SURGICAL PLASTERS
K861695
Salvaplast Industries
General & Plastic Surgery · 91d
Cleared Aug 01, 1986
REPLIANALYZER
K861958 · LON
Mct Medical, Inc.
Microbiology · 73d