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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
53641–53664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2009
INCLUSIVE ZIRCONIA ABUTMENT BLANKS
K083480 · NHA
Inclusive Dental Solutions
Dental · 162d
Cleared May 05, 2009
PANTHER REALART, MODEL 4.7
K083502 · MUJ
Prowess, Inc.
Radiology · 161d
Cleared May 05, 2009
ORTHADAPT PR
K090288 · FTL
Pegasus Biologics, Inc.
General & Plastic Surgery · 89d
Cleared May 05, 2009
ELECSYS RUBELLA IGG CALCHECK
K090311 · JJX
Roche Diagnostics
Microbiology · 88d
Cleared May 05, 2009
CONMED AER DEFENSE SMOKE EVACUATOR
K091139 · FYD
Conmed Corporation
General Hospital · 15d
Cleared May 05, 2009
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
K091160 · LLZ
Broncus Technologies, Inc.
Radiology · 14d
Cleared May 05, 2009
GE VENUE 40, MODEL 5324338
K091164 · IYN
Ge Medical Systems China Co., Ltd.
Radiology · 13d
Cleared May 05, 2009
NIO 2MP (MDNG-2121)
K091172 · LLZ
Barco N.V.
Radiology · 13d
Cleared May 04, 2009
LUME 2 SYSTEM, MODEL GA0005000
K083733 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 139d
Cleared May 04, 2009
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM
K090024 · HSX
Alexandria Research Technologies, LLC
Orthopedic · 119d
Cleared May 04, 2009
ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M
K090157 · MMK
Wcm Waste & Compliance Management, Inc.
General Hospital · 102d
Cleared May 04, 2009
MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)
K090182 · MUJ
Nuclemed S.A.
Radiology · 98d
Cleared May 04, 2009
PHILIPS M3001A MULTI MEASUREMENT SERVER
K090360 · DQA
Philips Medizin Systeme Boblingen GmbH
Anesthesiology · 81d
Cleared May 04, 2009
FOOTPRINT MEDICAL SILICONE FEEDING TUBE
K090559 · KNT
Footprint Medical
Gastroenterology & Urology · 63d
Cleared May 04, 2009
CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K090913 · DQY
Spectranetics Corp.
Cardiovascular · 33d
Cleared May 04, 2009
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE
K091016 · GAT
Surgical Devices, A Global Business...
General & Plastic Surgery · 25d
Cleared May 01, 2009
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
K080355 · HAW
Elekta Instrument AB
Neurology · 445d
Cleared May 01, 2009
MONTERIS MEDICAL AUTOLITT LASER PROBE
K081509 · GEX
Monteris Medical,
General & Plastic Surgery · 337d
Cleared May 01, 2009
ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
K081938 · LDP
Genzyme Diagnostics P.E.I., Inc.
Toxicology · 297d
Cleared May 01, 2009
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
K082529 · HIS
Alatech Healthcare, LLC
Obstetrics & Gynecology · 241d
Cleared May 01, 2009
KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
K082554 · FRG
Kimberly-Clark Corp.
General Hospital · 240d
Cleared May 01, 2009
OEC 9900 ELITE
K082781 · OWB
Ge Healthcare Surgery
Radiology · 221d
Cleared May 01, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
K083088 · OCC
Nanosphere, Inc.
Microbiology · 197d
Cleared May 01, 2009
BCI WW1030 PULSE OXIMETER
K083557 · DQA
Smiths Medical Pm, Inc.
Anesthesiology · 150d