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
72049–72072 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 2003
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE,...
K031518 · DWF
Medtronic Vascular
Cardiovascular · 7d
Cleared May 21, 2003
VARISEED 7.1
K030534 · KXK
Varian Medical Systems
Radiology · 90d
Cleared May 21, 2003
RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
K030544 · OWB
Sigma Vision, Inc.
Radiology · 90d
Cleared May 21, 2003
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K030558 · JAQ
Proxima Therapeutics, Inc.
Radiology · 89d
Cleared May 21, 2003
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II
K030576 · FRN
The Anspach Effort, Inc.
General Hospital · 86d
Cleared May 21, 2003
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K030589 · DQY
NuMED, Inc.
Cardiovascular · 85d
Cleared May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · DQX
Boston Scientific Scimed, Inc.
Cardiovascular · 84d
Cleared May 21, 2003
MYTHOS 500
K030805 · GEX
Msq (M2) , Ltd.
General & Plastic Surgery · 69d
Cleared May 21, 2003
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
K030812 · MHX
Datex-Ohmeda
Cardiovascular · 68d
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