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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
43561–43584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2012
VIALOK SINGLE VIAL ACCESS DEVICE VENTED
K122265 · LHI
Yukon Medical, LLC
General Hospital · 15d
Cleared Aug 14, 2012
TABLET COMMANDER
K122285 · DRG
Cardiocom, LLC
Cardiovascular · 15d
Cleared Aug 13, 2012
CERASORB PLUS
K120152 · NPM
Riemser Arzneimittel AG
Dental · 208d
Cleared Aug 13, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
K120446 · FDS
Fujinon, Inc.
Radiology · 181d
Cleared Aug 13, 2012
ERISMA-LP
K120469 · NKB
Clariance
Orthopedic · 179d
Cleared Aug 13, 2012
JOURNEY II CR KNEE SYSTEM
K121443 · JWH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Aug 13, 2012
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
K121667 · LOX
Boston Scientific Corp
Cardiovascular · 68d
Cleared Aug 13, 2012
SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE...
K121819 · FRO
Covalontechnologies, Inc.
General & Plastic Surgery · 53d
Cleared Aug 13, 2012
MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE...
K122246 · NRB
Celleration, Inc.
General & Plastic Surgery · 17d
Cleared Aug 10, 2012
SPIRALE DRUG DELIVERY SYSTEM
K111246 · CAF
Armstrong Medical , Ltd.
Anesthesiology · 464d
Cleared Aug 10, 2012
LIFECELL TISSUE EXPANDER
K112534 · LCJ
Lifecell Corp.
General & Plastic Surgery · 344d
Cleared Aug 10, 2012
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
K113210 · KXK
Isoaid, LLC
Radiology · 283d
Cleared Aug 10, 2012
MEDICAL AIR COMPRESSOR
K113338 · BTI
Oricare, Inc.
Anesthesiology · 270d
Cleared Aug 10, 2012
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · CDN
Alfa Wassermann Diagnostic...
Chemistry · 268d
Cleared Aug 10, 2012
BIOPSY DIGIT S BIOPSY SL
K113607 · IZH
Giotto USA, LLC
Radiology · 248d
Cleared Aug 10, 2012
POWDER FREE LATEX EXAMINATION GLOVES
K113685 · LYY
Khai Hoan Joint Stock Company
General Hospital · 239d
Cleared Aug 10, 2012
WIRELESS IMAGE TRANSMITTER UNIT
K120278 · GCJ
Olympus Medical Systems Corp.
General & Plastic Surgery · 193d
Cleared Aug 10, 2012
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY...
K120554 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 169d
Cleared Aug 10, 2012
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
K120715 · HSB
Zimmer GmbH
Orthopedic · 155d
Cleared Aug 10, 2012
ET/SS IMPLANT SYSTEM
K120847 · DZE
Osstem Implant Co., Ltd.
Dental · 143d
Cleared Aug 10, 2012
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
K121197 · DSI
Preventice, Inc.
Cardiovascular · 113d
Cleared Aug 10, 2012
C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
K121320 · ODP
Medyssey Co, Ltd.
Orthopedic · 100d
Cleared Aug 10, 2012
NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
K121368 · LZA
Matang Mfg. Sdn. Bhd.
General Hospital · 95d
Cleared Aug 10, 2012
LUBE JELLY SURINGE
K121390 · KMJ
Nurse Assist, Inc.
General Hospital · 93d