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
112537–112560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 28, 1993
URINE CALIBRATOR AND CONTROL
K931506 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 125d
Cleared Jul 28, 1993
COATED ORTHODONTIC DEVICES
K931631 · DZC
Wonder Wire
Dental · 117d
Cleared Jul 28, 1993
ENDOSWAB
K931898 · GCJ
Medline Industries, Inc.
General & Plastic Surgery · 100d
Cleared Jul 28, 1993
ENTREE THORACOSCOPY CANNULA SET
K932022 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 96d
Cleared Jul 28, 1993
CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3
K932658 · JJX
More Diagnostics
Chemistry · 56d
Cleared Jul 28, 1993
MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM
K932659 · JJX
More Diagnostics
Chemistry · 56d
Cleared Jul 27, 1993
ADA SHANK EXTENSION
K914724 · DZA
Implant Corp. of America
Dental · 648d
Cleared Jul 27, 1993
MULLER STRAIGHT STEM FEMORAL PROSTHESIS
K923808 · LZO
Techmedica, Inc.
Orthopedic · 363d
Cleared Jul 27, 1993
DENTAL OR SURGICAL BUR
K923883 · EJL
Stratum Dental Technologies, Inc.
Dental · 357d
Cleared Jul 27, 1993
RESTRAINING STRETCHER
K924275 · FPP
Dms
General Hospital · 336d
Cleared Jul 27, 1993
IVION ADMIN SETS W/FLOW CLIPS
K925219 · FPA
Ivion Corp.
General Hospital · 284d
Cleared Jul 27, 1993
ONE SYSTEM TAPERED TITANIUM ABUTMENTS
K925349 · NHA
Implant Support Systems, Inc.
Dental · 278d
Cleared Jul 27, 1993
LIFE ISLAND 21
K925651 · FNM
Keisei (Usa) Co., Ltd.
General Hospital · 260d
Cleared Jul 27, 1993
SKYTRON LIFE ISLAND 21
K926045 · FNM
Skytron, Div. the Kmw Group, Inc.
General Hospital · 238d
Cleared Jul 27, 1993
VACUUM POWER BODY FLUID SUCTION APPARATUS
K926140 · KDP
Hill-Rom, Inc.
General Hospital · 232d
Cleared Jul 27, 1993
DOUGLAS MEDICAL PRODUCTS, INC. VENTED SPIKE ADAPT
K926184 · FPA
Douglas Medical Products Corp.
General Hospital · 231d
Cleared Jul 27, 1993
ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT
K926396 · CKG
Nichols Institute
Chemistry · 218d
Cleared Jul 27, 1993
SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES
K930218 · MAJ
Concord/Portex
General Hospital · 193d
Cleared Jul 27, 1993
FLH1768M SERIES HOSPITAL BED
K930234 · FNL
Bertec Medical, Inc.
General Hospital · 189d
Cleared Jul 27, 1993
REFIX(TM) SYSTEM
K930279 · IYE
Nomos Corp.
Radiology · 187d
Cleared Jul 27, 1993
DELFIA CORTISOL KIT
K930732 · JFT
Wallac OY
Chemistry · 166d
Cleared Jul 27, 1993
VALLEYLAB RETRACTABLE ELECTRODES
K931028 · GEI
Valleylab, Inc.
General & Plastic Surgery · 148d
Cleared Jul 27, 1993
VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT
K931031 · JFT
Biomerieux Vitek, Inc.
Chemistry · 148d
Cleared Jul 27, 1993
GCA-7200A
K931297 · KPS
Toshiba America Medical Systems, In.C
Radiology · 134d