Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
76465–76488 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 30, 2002
DIGI-PRO TENS MODEL WL-2203 AND WL-2205
K021359 · GZJ
Well-Life Healthcare, Inc.
Neurology · 90d
Cleared Apr 29, 2002
REPROCESSED GUIDEWIRES
K012556 · NML
Sterilmed, Inc.
Gastroenterology & Urology · 264d
Cleared Apr 29, 2002
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
K013471 · LNS
E.S.W.L. Products, Inc.
Gastroenterology & Urology · 193d
Cleared Apr 29, 2002
GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
K020208 · NBW
Bayer Group Diagnostics
Chemistry · 97d
Cleared Apr 29, 2002
CLEARVIEW WRIST FIXATOR
K020311 · KTT
Rigid FX Orthopedics, Incorporated
Orthopedic · 90d
Cleared Apr 29, 2002
QUANTA LITE CCP ELISA
K020414 · NHX
Inova Diagnostics, Inc.
Immunology · 81d
Cleared Apr 29, 2002
EVANS SUB-Q, MODEL MC4206
K020530 · FPA
Evans Medical, Inc.
General Hospital · 69d
Cleared Apr 29, 2002
ETEST ERTAPENEM
K020748 · JWY
Ab Biodisk
Microbiology · 53d
Cleared Apr 29, 2002
CALIBRATING MATERIAL, CAL-PAK, BUFFERS
K020894 · JIT
Mission Diagnostics
Chemistry · 41d
Cleared Apr 29, 2002
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
K020911 · HQE
Medical Instrument Development...
Ophthalmic · 40d
Cleared Apr 29, 2002
BUSSE UMBILICAL CORD CLAMP CUTTER
K021055 · HFW
Busse Hospital Disposables, Inc.
Obstetrics & Gynecology · 28d
Cleared Apr 29, 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
K021155 · JJW
Medical Analysis Systems, Inc.
Chemistry · 19d
Cleared Apr 26, 2002
CRYOPEN AND ACCESSORIES
K012214 · GEH
Cimex Biotech, LLC
General & Plastic Surgery · 284d
Cleared Apr 26, 2002
MICROJET CRONO
K013234 · FRN
Cane S.R.L.
General Hospital · 211d
Cleared Apr 26, 2002
MICROJET MODEL # CD4 AND CD4/20
K013776 · FRN
Cane S.R.I.
General Hospital · 164d
Cleared Apr 26, 2002
MALE LATEX CONDOM WITH RIBBED SURFACE
K020272 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 88d