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
108937–108960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 06, 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · CEP
Bio-Rad Laboratories, Inc.
Chemistry · 58d
Cleared Apr 06, 1994
SPECTACLE FRAMES
K940560 · HQZ
Optical Xpressions, Ltd.
Ophthalmic · 58d
Cleared Apr 06, 1994
E.M.A.
K940614 · HQZ
European Manufacturers Agency, Inc.
Ophthalmic · 51d
Cleared Apr 06, 1994
SUNGLASSES (NON-PRESCRIPTION)
K940778 · HQY
Hwa Meei Optical Co., Ltd.
Ophthalmic · 43d
Cleared Apr 06, 1994
VECTOR WHEELCHAIR
K941236 · IOR
Vector Mobility, Inc.
Physical Medicine · 22d
Cleared Apr 05, 1994
DECOMAT 228
K920406 · MDZ
Getinge International, Inc.
General Hospital · 795d
Cleared Apr 05, 1994
DECOMAT A 8666
K920413 · MDZ
Getinge International, Inc.
General Hospital · 795d
Cleared Apr 05, 1994
CL HIP STEM H/A COATED
K922613 · MEH
Lima Intl. Corp.
Orthopedic · 672d
Cleared Apr 05, 1994
AKCESS-CATH
K925818 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 504d
Cleared Apr 05, 1994
CANNULATED MALLEOLAR SCREW
K931682 · KWK
Onyx Medical Corp.
Orthopedic · 365d
Cleared Apr 05, 1994
MALLEOLAR SCREW
K931686 · KTW
Onyx Medical Corp.
Orthopedic · 365d
Cleared Apr 05, 1994
R AND D BATTERY REPLACEMENT
K933337 · KIJ
R & D Batteries, Inc.
Orthopedic · 271d
Cleared Apr 05, 1994
POWDER FREE GLOVES
K935088 · LYY
Avt Rubber Products , Ltd.
General Hospital · 162d
Cleared Apr 05, 1994
PARA 5 DIFF
K935196 · JPK
Streck Laboratories, Inc.
Hematology · 161d
Cleared Apr 05, 1994
SCHUCO-VAC MODEL 178
K935218 · JCX
Schuco, Inc.
General & Plastic Surgery · 161d
Cleared Apr 05, 1994
RADIAS MONOCLONAL HBA 1C ASSAY
K935613 · LCP
Bio-Rad
Hematology · 134d
Cleared Apr 05, 1994
CEDIA(R) DAU PCP ASSAY
K935650 · LCM
Microgenics Corp.
Toxicology · 133d
Cleared Apr 05, 1994
SYNERMED ISE REAGENTS
K940194 · JGS
Synermed, Inc.
Chemistry · 82d
Cleared Apr 05, 1994
DOCUMENT(R) ZERO
K940568 · JJX
Casco Standards
Chemistry · 56d
Cleared Apr 05, 1994
TAN AMERICA SUN UP
K940753 · LEJ
Tan America
General & Plastic Surgery · 46d
Cleared Apr 04, 1994
TBC TRAUMA SUIT PROTECTIVE GOWN
K923162 · FYC
Tbc, Inc.
General Hospital · 644d
Cleared Apr 04, 1994
JOBST-CUSTOM
K925154 · DWL
Jobst Institute, Inc.
General Hospital · 538d
Cleared Apr 04, 1994
JOBSKIN CONTINUING CARE
K925583 · MDA
Jobst Institute, Inc.
General & Plastic Surgery · 515d
Cleared Apr 04, 1994
TMC I, II
K930534 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 426d