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
95809–95832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1996
ASTA-CATH
K961361 · GBM
A+ Products
Gastroenterology & Urology · 205d
Cleared Oct 31, 1996
AUTOMATIC TUBING CLAMP SYSTEM (ATC)
K961364 · KRL
Rocky Mountain Research, Inc.
Cardiovascular · 205d
Cleared Oct 31, 1996
THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
K961621 · ILO
Therapy Concepts, Inc.
Physical Medicine · 188d
Cleared Oct 31, 1996
MRS-2D
K961645 · HCC
Lexicor Medical Technology, Inc.
Neurology · 185d
Cleared Oct 31, 1996
COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY...
K961784 · LQN
Sienna Biotech, Inc.
Microbiology · 182d
Cleared Oct 31, 1996
NEUROMAG-122
K962764 · OLY
Philips Medical Systems (Cleveland),...
Neurology · 107d
Cleared Oct 31, 1996
CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS
K962993 · GEX
Cynosure, Inc.
General & Plastic Surgery · 91d
Cleared Oct 31, 1996
HEELBO LIFE JACKET WITH CROTCH SUPPORT
K963041 · FMQ
Heelbo, Inc.
General Hospital · 87d
Cleared Oct 31, 1996
EZ-SCREEN PROFILE
K963233 · LCM
Editek, Inc.
Toxicology · 73d
Cleared Oct 31, 1996
V-LINK 3.2 FOR WINDOWS
K963274 · IYO
Koven Technology, Inc.
Radiology · 72d
Cleared Oct 31, 1996
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K963292 · CIC
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 31, 1996
MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
K963393 · FMQ
Depuy, Inc.
General Hospital · 64d
Cleared Oct 31, 1996
MORRISON MEDICAL WRIST RESTRAINT
K963419 · FMQ
Morrison Medical Products
General Hospital · 62d
Cleared Oct 31, 1996
UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS
K963527 · FMQ
Alimed, Inc.
General Hospital · 57d
Cleared Oct 31, 1996
3M PROPLUS SYSTEM
K963766 · ELW
3M Company
Dental · 42d
Cleared Oct 30, 1996
BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
K954850 · DTZ
C.R. Bard, Inc.
Cardiovascular · 373d
Cleared Oct 30, 1996
BARD QUANTUM CVR
K962726 · DTP
C.R. Bard, Inc.
Cardiovascular · 107d
Cleared Oct 30, 1996
CEDIA DAU OPIATE 2K ASSAY
K962795 · DJG
Boehringer Mannheim Corp.
Toxicology · 104d
Cleared Oct 30, 1996
COULTER GEN-S SYSTEM
K962988 · GKL
Coulter Corp.
Hematology · 90d
Cleared Oct 30, 1996
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
K963188 · EFQ
Codi International BV
General & Plastic Surgery · 76d
Cleared Oct 30, 1996
BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES,...
K963218 · KGO
American Bantex Corp.
General Hospital · 75d
Cleared Oct 30, 1996
RMS K-WIRE
K963367 · HTY
Rms Div.
Orthopedic · 64d
Cleared Oct 30, 1996
VERDICT THC
K963516 · LDJ
Editek, Inc.
Toxicology · 57d
Cleared Oct 30, 1996
VERDICT BARBITURATES
K963529 · DIS
Editek, Inc.
Toxicology · 56d