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
41737–41760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 20, 2013
OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC...
K123832 · HRS
The Orthopaedic Implant Company (Oic)
Orthopedic · 97d
Cleared Mar 20, 2013
CEREC BLOCS C IN
K123952 · EIH
Sirona Dental Systems GmbH
Dental · 89d
Cleared Mar 20, 2013
PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130206 · ODG
Pentax of America, Inc.
Radiology · 51d
Cleared Mar 20, 2013
SUITEHEART
K130228 · LLZ
Neosoft, LLC
Radiology · 50d
Cleared Mar 20, 2013
PALM BLADDER SCANNER
K130229 · IYO
Mianyang Meike Electronic Equipment...
Radiology · 50d
Cleared Mar 20, 2013
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
K130247 · ODG
Pentax of America, Inc.
Radiology · 47d
Cleared Mar 20, 2013
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
K130252 · DQY
St Jude Medical
Cardiovascular · 47d
Cleared Mar 20, 2013
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
K130257 · DQY
St Jude Medical
Cardiovascular · 47d
Cleared Mar 20, 2013
MIRADA RTX
K130393 · LLZ
Mirada Medical, Ltd.
Radiology · 33d
Cleared Mar 20, 2013
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR,...
K130433 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 27d
Cleared Mar 19, 2013
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS...
K122220 · LPL
Soflex Limited
Ophthalmic · 237d
Cleared Mar 19, 2013
DENTOETCH QUICKBOND BOND ACTIVATOR
K122522 · KLE
Itena Clinical
Dental · 211d
Cleared Mar 19, 2013
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
K122940 · DQY
Cook, Inc.
Cardiovascular · 176d
Cleared Mar 19, 2013
DIGITAL RETINAL CAMERA
K123208 · HKI
Canon Inc. -Medical Equipment Group
Ophthalmic · 158d
Cleared Mar 19, 2013
IOGYN ENDOSCOPE
K123330 · HIH
Iogyn, Inc.
Obstetrics & Gynecology · 144d
Cleared Mar 19, 2013
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · DTM
Medtronic Perfusion Systems
Cardiovascular · 139d
Cleared Mar 19, 2013
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
K123415 · DZE
Biodenta Swiss AG
Dental · 134d
Cleared Mar 19, 2013
VIA MICROCATHETER, VIA PLUS MICROCATHETER
K123477 · KRA
Sequent Medical, Inc.
Cardiovascular · 126d
Cleared Mar 19, 2013
CADWELL DISPOSABLE PROBE HANDLE
K123589 · PDQ
Cadwell
Neurology · 118d
Cleared Mar 19, 2013
GUIDEZILLA GUIDE EXTENSION CATHETER
K123765 · DQY
Boston Scientific
Cardiovascular · 102d
Cleared Mar 19, 2013
AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET
K130157 · JJX
Aalto Scientific, Ltd.
Chemistry · 55d
Cleared Mar 19, 2013
ORBIT INFUSION SET
K130468 · FPA
Ypsomed AG
General Hospital · 22d
Cleared Mar 18, 2013
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR...
K122059 · MBI
Smith & Nephew, Inc.
Orthopedic · 248d
Cleared Mar 18, 2013
BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR
K122702 · ONT
Filligent Limited
General Hospital · 195d