FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
75841–75864 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 2002
GUIDANT BALLOON CATHETER, SEVERAL MODELS
K021283 · DQO
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
EASYTRAK GUIDING CATHETER
K021284 · DQY
Guidant Corp.
Cardiovascular · 14d
Cleared May 02, 2002
HI-TORQUE EXTRA S'PORT GUIDEWIRE
K021285 · DQX
Guidant Corp.
Cardiovascular · 14d
Cleared May 01, 2002
KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS
K011859 · DWJ
Klimamed Technologie Medizingerate GmbH
Cardiovascular · 321d
Cleared May 01, 2002
KENDALL, SEQUENTIAL COMPRESSION DEVICE
K012614 · JOW
Medical Instruments Technology, Inc.
Cardiovascular · 261d
Cleared May 01, 2002
FRC POSTEC
K013802 · ELR
Ivoclar Vivadent, Inc.
Dental · 167d
Cleared May 01, 2002
FIXATION (STEINMANN) PINS
K013888 · HTY
Miltex, Inc.
Orthopedic · 159d
Cleared May 01, 2002
SAFE SHIELD POWEDER-FREE LATEX EXAMINATION GLOVES
K020053 · LYY
Safe Shield Co., Ltd.
General Hospital · 113d
Cleared May 01, 2002
SOLO ORTHO 3
K020502 · DYH
Sybron Dental Specialties, Inc.
Dental · 76d
Cleared May 01, 2002
VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VRE
K020576 · NIJ
Id Biomedical Corp.
Microbiology · 69d
Cleared May 01, 2002
GRIDLOCK 195 ADHESIVE
K020648 · DYH
Allodex Systems
Dental · 62d
Cleared May 01, 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · EOB
Olympus America, Inc.
Ear, Nose, Throat · 29d
Cleared May 01, 2002
OLYMPUS BF TYPE UM40
K021204 · PSV
Olympus Optical Co., Ltd.
Radiology · 15d
Cleared May 01, 2002
AROX 53-BP
K021217 · DTB
Biotronik, Inc.
Cardiovascular · 14d
Cleared Apr 30, 2002
PATTON TRIPOL
K012279 · GEI
Patton Medical Corp.
General & Plastic Surgery · 285d
Cleared Apr 30, 2002
GLUCOMETER DEX BLOOD GLUCOSE SYSTEM (MODIFIED)
K020210 · NBW
Bayer Group Diagnostics
Chemistry · 98d
Cleared Apr 30, 2002
DIGI-PRO TENS, MODEL WL-2204 AND WL-2205
K020314 · IPF
Well-Life Healthcare, Inc.
Physical Medicine · 90d
Cleared Apr 30, 2002
BCI 3180 PULSE OXIMETER
K020350 · DQA
Bci, Inc.
Anesthesiology · 85d
Cleared Apr 30, 2002
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
K020366 · DPS
Cardiocomm Solutions, Inc.
Cardiovascular · 85d
Cleared Apr 30, 2002
EAV KINDLING 2000S GSR DEVICE
K020564 · GZO
Virbrant Health
Neurology · 69d
Cleared Apr 30, 2002
EAV COMBI-2
K020565 · GZO
Vibrant Health
Neurology · 69d
Cleared Apr 30, 2002
AKUPORT M-2
K020568 · GZO
Vibrant Health
Neurology · 69d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL -...
K020686 · JWY
Dade Microscan, Inc.
Microbiology · 57d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
K020691 · JWY
Dade Microscan, Inc.
Microbiology · 57d