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
114745–114768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1993
NUTEX GLOVES
K920745 · KGO
Ansell Intl.
General Hospital · 349d
Cleared Jan 21, 1993
INMAN MEDICAL PACKING STRIP
K921291 · FER
Inman Medical Corp.
Gastroenterology & Urology · 316d
Cleared Jan 21, 1993
MICROPROTEIN REAGENT SET
K921412 · CEK
Sterling Diagnostics, Inc.
Chemistry · 303d
Cleared Jan 21, 1993
HOSPITAL KIT ENT 1125
K922126 · LRP
Savoy Medical Supply Co., Inc.
General & Plastic Surgery · 260d
Cleared Jan 21, 1993
SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS
K922145 · KAM
Atos Medical AB
General & Plastic Surgery · 259d
Cleared Jan 21, 1993
RAYTEL DIGITAL IMAGING SYSTEMS
K922164 · LMD
Olicon Imaging Systems, Inc.
Radiology · 258d
Cleared Jan 21, 1993
PHILIPS PRE-FILTER OPTION
K923141 · ITY
Philips Medical Systems, Inc.
Radiology · 206d
Cleared Jan 21, 1993
HEALTHPAK X-RAY SOX BARRIERS
K923307 · EAP
Healthpak, Inc.
Radiology · 258d
Cleared Jan 21, 1993
SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL
K923580 · HSB
Synthes (Usa)
Orthopedic · 185d
Cleared Jan 21, 1993
SYNTHES TITANIUM UNREAMED FEMORAL NAIL
K923597 · HSB
Synthes (Usa)
Orthopedic · 185d
Cleared Jan 21, 1993
EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI
K923681 · DYB
Exonix Research Corp.
Cardiovascular · 183d
Cleared Jan 21, 1993
ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM
K923761 · JPA
International Technidyne Corp.
Hematology · 177d
Cleared Jan 21, 1993
ETHYL ALCOHOL ASSAY
K923783 · DMT
Diagnostic Reagents, Inc.
Toxicology · 177d
Cleared Jan 21, 1993
MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
K924116 · DXT
Medrad, Inc.
Cardiovascular · 160d
Cleared Jan 21, 1993
PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC
K924310 · LLZ
GE Medical Systems
Radiology · 148d
Cleared Jan 21, 1993
AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ
K924458 · IYO
Acoustic Imaging Technologies Corp.
Radiology · 141d
Cleared Jan 21, 1993
AE-206 TYMPNOMWRWE(R) AUDIOMETER
K924933 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 113d
Cleared Jan 21, 1993
AUTOMATIC IMPEDANCE METER AE-205
K924934 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 113d
Cleared Jan 21, 1993
FLUID COOLED BONE SAW BLADE, 6000 SERIES
K924953 · GFA
Boehringer Laboratories
General & Plastic Surgery · 113d
Cleared Jan 21, 1993
IMAGESSSHARE 910
K925284 · LMD
Dejarnette Research Systems
Radiology · 93d
Cleared Jan 21, 1993
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
K925344 · GKZ
Coulter Corp.
Hematology · 91d
Cleared Jan 21, 1993
AUTOSTAT ANTITHYROGLOBIN
K925784 · JZO
Cogent Diagnotics , Ltd.
Immunology · 79d
Cleared Jan 21, 1993
AUTOSTAT ANTI-THYROID MICROSOMAL KIT
K925785 · JZO
Cogent Diagnotics , Ltd.
Immunology · 79d
Cleared Jan 21, 1993
9600 FLUOROSCOPIC IMAGING SYSTEM
K926056 · OXO
Oec-Diasonics, Inc.
Radiology · 51d