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
41905–41928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2013
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL...
K123675 · FED
Coloplast A/S
Gastroenterology & Urology · 91d
Cleared Mar 01, 2013
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE
K123749 · LZA
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 85d
Cleared Mar 01, 2013
VITA ENAMIC STAINS
K123761 · EBD
Innovation Meditech GmbH
Dental · 84d
Cleared Mar 01, 2013
TRANSTEK BLOOD PRESSURE MONITOR
K123780 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 81d
Cleared Mar 01, 2013
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
K123802 · CIG
Medica Corp.
Chemistry · 81d
Cleared Mar 01, 2013
COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR...
K123812 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 80d
Cleared Mar 01, 2013
DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS
K123924 · LZO
Depuy Orthopaedics
Orthopedic · 71d
Cleared Mar 01, 2013
MUSE CARDIOLOGY INFORMATION SYSTEM
K130155 · DQK
Ge Medical Systems Information...
Cardiovascular · 38d
Cleared Mar 01, 2013
LIQUID ASSAYED MULTIQUAL PREMIUM
K130162 · JJY
Bio-Rad Laboratories
Chemistry · 37d
Cleared Mar 01, 2013
ILAB ULTRASOUND IMAGING SYSTEM
K130243 · IYO
Boston Scientific Corp
Radiology · 29d
Cleared Mar 01, 2013
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH...
K130245 · FMG
Baxter Healthcare Corp
General Hospital · 29d
Cleared Mar 01, 2013
MAGNETOM ESSENZA WITH SYNGO MR D14
K130262 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Feb 28, 2013
TI-MAX Z45
K121901 · EGS
Nakanishi, Inc.
Dental · 244d
Cleared Feb 28, 2013
U-RIGHT COMPRESSOR NEBULIZER
K121969 · CAF
Taidoc Technology Corporation
Anesthesiology · 238d
Cleared Feb 28, 2013
GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
K121999 · FLL
Draeger Medical GmbH
General Hospital · 234d
Cleared Feb 28, 2013
SYNTHES PATIENT SPECIFIC PLATE
K122647 · JEY
Synthes, Inc.
Dental · 182d
Cleared Feb 28, 2013
INTERVERTEBRAL BODY FUSION DEVICE
K122872 · ODP
Dio Medical Co., Ltd.
Orthopedic · 162d
Cleared Feb 28, 2013
ANKLE TRAUMA SYSTEM
K122936 · HRS
Orthopro, LLC
Orthopedic · 157d
Cleared Feb 28, 2013
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
K123195 · CCL
GE Healthcare Finland Oy
Anesthesiology · 140d
Cleared Feb 28, 2013
DURABLUE STERILIZATION WRAP
K123289 · FRG
Cardinal Health-Medical Products and...
General Hospital · 129d
Cleared Feb 28, 2013
CLEAR ALIGNER ADHESIVE
K123348 · DYH
Reliance Orthodontic Products, Inc.
Dental · 120d
Cleared Feb 28, 2013
FACET SCREW SYSTEM
K123497 · MRW
Facet-Link, Inc.
Orthopedic · 107d
Cleared Feb 28, 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679 · FRO
3M Company
General & Plastic Surgery · 90d
Cleared Feb 28, 2013
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
K123707 · DQX
Cook, Inc.
Cardiovascular · 87d