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
70225–70248 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2003
VACURECT VACUUM CONSTRICTION DEVICE
K032776 · LKY
Vacurect Manufacturing (Pty) , Ltd.
Gastroenterology & Urology · 25d
Cleared Oct 02, 2003
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
K031439 · ELW
Harry J. Bosworth Co.
Dental · 149d
Cleared Oct 02, 2003
3D INVIVO BY CSIST
K031567 · LLZ
Chung-Shan Institute of Science and...
Radiology · 136d
Cleared Oct 02, 2003
SECTRA ORTHOPEDIC PACKAGE
K031590 · LLZ
Sectra-Imtec AB
Radiology · 134d
Cleared Oct 02, 2003
AQUABOSS ECORO DIA 50
K032004 · FIP
Lauer Ltd., Hong Kong
Gastroenterology & Urology · 94d
Cleared Oct 02, 2003
HLS NOETOS SYSTEM
K032079 · JWH
Tornier
Orthopedic · 87d
Cleared Oct 02, 2003
I-BEAM
K032100 · IYE
Computerized Medical Systems, Inc.
Radiology · 86d
Cleared Oct 02, 2003
5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K032140 · DZE
Innova Life Sciences Corp.
Dental · 83d
Cleared Oct 02, 2003
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE...
K032177 · FDS
Olympus Opto-Electronics Co., Ltd.
Gastroenterology & Urology · 78d
Cleared Oct 02, 2003
ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
K032210 · MQB
Alara, Inc.
Radiology · 73d
Cleared Oct 02, 2003
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS...
K032234 · EFB
Mk-Dent GmbH
Dental · 73d
Cleared Oct 02, 2003
MINICAT DENTOCAT
K032243 · JAK
Xoran Technologies, Inc.
Radiology · 72d
Cleared Oct 02, 2003
XIVE TG ABUTMENTS
K032302 · DZE
Friadent GmbH
Dental · 69d
Cleared Oct 02, 2003
ECHOENCODER
K032324 · LLZ
Icardiogram, Incorporated
Radiology · 66d
Cleared Oct 02, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
K032344 · EZX
Implex Corp.
General & Plastic Surgery · 64d
Cleared Oct 02, 2003
EDWARDS PERIPHERAL DILATATION CATHETER
K032587 · DQY
Edwards Lifesciences, LLC
Cardiovascular · 41d
Cleared Oct 02, 2003
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES
K032616 · LYZ
Elite International, Inc.
General Hospital · 38d
Cleared Oct 02, 2003
IMMIX PLASTIFILM
K032673 · FTL
Osteobiologics, Inc.
General & Plastic Surgery · 34d
Cleared Oct 02, 2003
HL888BF
K032695 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Oct 02, 2003
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Oct 02, 2003
CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA...
K032737 · DQY
Cordis Europa, N.V.
Cardiovascular · 28d
Cleared Oct 02, 2003
MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE
K032750 · DZE
Friandent GmbH
Dental · 27d
Cleared Oct 02, 2003
MICROMLC
K032790 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared Oct 02, 2003
OPTICAL SEPARATOR
K032889 · GCJ
Applied Medical Resources
General & Plastic Surgery · 15d