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
71545–71568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2003
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
K030828 · GKZ
Beckman Coulter, Inc.
Hematology · 68d
Cleared May 21, 2003
ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
K031001 · FAS
Acmi Corporation
Gastroenterology & Urology · 51d
Cleared May 21, 2003
FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE
K031020 · LYY
Pt. Mandiri Inti Buana
General Hospital · 51d
Cleared May 21, 2003
SPIN DOWN RAPIDFLAP
K031034 · GXN
Walter Lorenz Surgical, Inc.
Neurology · 50d
Cleared May 21, 2003
EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE
K031079 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 47d
Cleared May 21, 2003
EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
K031081 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 47d
Cleared May 21, 2003
EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK
K031082 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 47d
Cleared May 21, 2003
COOL TOUCH 3
K031184 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 36d
Cleared May 21, 2003
RADIOMED SOFT TISSUE MARKER
K031206 · JAK
Radiomed Corp.
Radiology · 35d
Cleared May 21, 2003
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
K031447 · MQB
Canon, Inc.
Radiology · 14d
Cleared May 20, 2003
BODY CLOCK TENS N' TONE
K022849 · GZJ
Body Clock Health Care, Ltd.
Neurology · 266d
Cleared May 20, 2003
HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
K022998 · IPF
Home Care Technology Co., Ltd.
Physical Medicine · 253d
Cleared May 20, 2003
OSSATURA BCP BONE VOID FILLER
K030131 · MQV
Isotis NV
Orthopedic · 126d
Cleared May 20, 2003
COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202
K030355 · ITI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 106d
Cleared May 20, 2003
COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103
K030356 · ITI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 106d
Cleared May 20, 2003
SR-130
K030494 · IZL
Source-Ray, Inc.
Radiology · 90d
Cleared May 20, 2003
FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES,...
K030497 · KPO
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared May 20, 2003
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
K030502 · MSD
Medcomp
Gastroenterology & Urology · 90d
Cleared May 20, 2003
T.E.A.R. TECH3 MODEL #44TT03
K030507 · IPF
Vision Quest Industries, Inc.
Physical Medicine · 90d
Cleared May 20, 2003
DEPILASE TRIO LASE LASER SYSTEM
K030508 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 90d
Cleared May 20, 2003
AMERITEK SURE-POINT TRACKER SYSTEM
K030518 · ITX
Amertek Medical, Inc.
Radiology · 90d
Cleared May 20, 2003
LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
K030527 · GEX
Lumenis
General & Plastic Surgery · 90d
Cleared May 20, 2003
CALLOS
K030554 · MQV
Skeletal Kinetics, LLC
Orthopedic · 88d
Cleared May 20, 2003
EVERSTICK POST
K030820 · ELR
Stick Tech , Ltd.
Dental · 67d