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
150553–150576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1984
TANDEM - EPRL
K843804 · CFT
Hybritech, Inc.
Chemistry · 47d
Cleared Nov 13, 1984
MICRO HEMATOCRIT CAPILLARY TUBES
K843892 · GIO
Abco Dealers, Inc.
Hematology · 41d
Cleared Nov 13, 1984
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
K844045 · DXT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 27d
Cleared Nov 13, 1984
CODE-A-WALL SERIES 1-250 INOCULUM TRAY
K844058
Plastic Injectors, Inc.
Microbiology · 26d
Cleared Nov 13, 1984
POS COMBO PANEL
K844086 · JTO
American Micro Scan
Microbiology · 22d
Cleared Nov 13, 1984
UREA NITROGEN REAGENT SET
K844156 · CDW
Livonia Diagnostics, Inc.
Chemistry · 20d
Cleared Nov 09, 1984
PERFOURM
K842324 · ELW
Cutter Laboratories, Inc.
Dental · 149d
Cleared Nov 09, 1984
SLS 3500 LED VISUAL STIMULATOR
K842381 · GWE
Nihon Kohden America, Inc.
Neurology · 144d
Cleared Nov 09, 1984
TITAN GEL ISO DOT LDH KIT
K842669 · CFE
Helena Laboratories
Chemistry · 122d
Cleared Nov 09, 1984
A.S.P.C./CLEARSOUND
K842832 · ESD
Asl, Inc.
Ear, Nose, Throat · 112d
Cleared Nov 09, 1984
ORTHODONTIC WIRE
K843722 · DZC
Arthur L. Wool
Dental · 46d
Cleared Nov 09, 1984
UNITEK CONVERTIBLE CAP REMOVER TOOL
K843742 · JEX
Unitek Corp.
Dental · 45d
Cleared Nov 09, 1984
BEHIND-THE-EAR 123 VTH
K843791 · ESD
Danavox, Inc.
Ear, Nose, Throat · 43d
Cleared Nov 09, 1984
RIONET HEARING AID HB-73
K844000 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared Nov 09, 1984
TRIGLYCERIDE REAGENT
K844032 · CDT
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Nov 09, 1984
FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS
K844047 · JIT
Fisher Diagnostics
Chemistry · 23d
Cleared Nov 09, 1984
VOLUMATIC
K844169 · KCD
Glaxo, Inc.
Ear, Nose, Throat · 15d
Cleared Nov 09, 1984
INORGANIC PHOSPHORUS REAGENT SET
K844182 · CEO
Livonia Diagnostics, Inc.
Chemistry · 14d
Cleared Nov 08, 1984
COMFEEL POWDER
K834343 · KOZ
Coloplast A/S
General & Plastic Surgery · 332d
Cleared Nov 08, 1984
LUER LOCKING ADAPTER(MATERIAL CHANGE)
K840815 · FOZ
Quinton, Inc.
General Hospital · 255d
Cleared Nov 08, 1984
PORTABLE NURSING UNIT TERMINAL
K841246 · DXN
Ncr Corp.
Cardiovascular · 230d
Cleared Nov 08, 1984
CO2 SURGICAL LASER SYSTEM XML-10
K841860 · EWG
Xanar, Inc.
Ear, Nose, Throat · 188d
Cleared Nov 08, 1984
EZ EYE DROP AID
K841896
Buckman Co., Inc.
Ophthalmic · 185d
Cleared Nov 08, 1984
IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS
K842217 · JAA
Micro Consultants, Inc.
Radiology · 157d