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
45073–45096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2012
TRU LEGIONELLA
K113190 · MJH
Meridian Bioscience, Inc.
Microbiology · 116d
Cleared Feb 24, 2012
SONY LMD-2451MT LCD MONITOR
K113203 · GCJ
Sony Electronics, Inc.
General & Plastic Surgery · 116d
Cleared Feb 24, 2012
SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR...
K113254 · PHX
Lima Corporate S.P.A.
Orthopedic · 113d
Cleared Feb 24, 2012
Q. FREEZE (MOTION VUE2)
K113408 · KPS
Ge Medical Systems, LLC
Radiology · 98d
Cleared Feb 24, 2012
14 WIRE STANDARD, 14 WIRE LS
K113454 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 95d
Cleared Feb 24, 2012
AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)
K113587 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 81d
Cleared Feb 24, 2012
MASIMO SET REUSABLE OXIMETRY SENSORS
K113596 · DQA
Masimo Corporation
Anesthesiology · 81d
Cleared Feb 24, 2012
ENVOY DISTAL ACCESS GUIDING CATHETER
K120229 · DQY
Codman & Shurtleff, Inc.
Cardiovascular · 30d
Cleared Feb 24, 2012
LINEAR HIP STEM, SIZE 5
K120241 · LPH
Encore Medical, L.P.
Orthopedic · 28d
Cleared CT Feb 24, 2012
JETSTREAM NAVITUS L SYSTEM
K120242 · MCW
Pathway Medical Technologies, Inc.
Cardiovascular · 28d
Cleared Feb 24, 2012
MEDIGUIDE TECHNOLOGY
K120301 · DQK
St. Jude Medical, Mediguide...
Cardiovascular · 24d
Cleared Feb 24, 2012
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
K120314 · MRZ
Welldoc, Inc.
General Hospital · 23d
Cleared Feb 24, 2012
CONNEX WORKSTATION
K120343 · MWI
Welch Allyn, Inc.
Cardiovascular · 21d
Cleared Feb 24, 2012
Q50 PLUS STENT GRAFT BALLOON CATHETER
K120381 · DQY
Qxmedical, LLC
Cardiovascular · 17d
Cleared Feb 23, 2012
INVENDO C20 COLONOSCOPY SYSTEM
K100624 · FDF
Invendo Medical Gbmh
Gastroenterology & Urology · 721d
Cleared Feb 23, 2012
BLUESHINE'S GOLD SERIES
K110375 · PDZ
Blueshine Srl
General & Plastic Surgery · 379d
Cleared Feb 23, 2012
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
K111970 · KRR
Tornier
Orthopedic · 227d
Cleared Feb 23, 2012
KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10
K112758 · DZE
Kat Implants, LLC
Dental · 154d
Cleared Feb 23, 2012
UPSTREAM SUPPORT CATHETER
K112886 · DQY
Upstream Peripheral Technologies
Cardiovascular · 146d
Cleared Feb 23, 2012
ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
K113222 · EFB
Nakamura Dental Handpiece Mfg. Co., Ltd.
Dental · 114d
Cleared Feb 23, 2012
PROULTRA PIEZO ULTRASONIC
K113430 · ELC
Satelec - Acteon Group
Dental · 94d
Cleared Feb 23, 2012
SUREFIRE GUIDE SHEATH
K113737 · DQO
Surefire Medical, Inc.
Cardiovascular · 65d
Cleared Feb 23, 2012
FIXATE TISSUE BAND
K113805 · GZB
Anulex Technologies, Inc.
General & Plastic Surgery · 62d
Cleared Feb 23, 2012
COLLAGEN RIBBON
K120019 · FTM
Wrightmedicaltechnologyinc
General & Plastic Surgery · 51d