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
142249–142272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1986
HALL DUNBAR DRILL GUIDE SYSTEM
K864163 · HRX
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 28d
Cleared Nov 20, 1986
MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD
K864287 · DTB
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 19, 1986
CATHETER VALVES KV 100 & KV 100EH
K861699 · KOD
Max Staubli , Ltd.
Gastroenterology & Urology · 198d
Cleared Nov 19, 1986
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM
K862598 · LNK
Laserscope
Gastroenterology & Urology · 141d
Cleared Nov 19, 1986
ZINETICS GASTROMETER (TM)
K862727 · FFT
Zinetics Medical Technology Corp.
Gastroenterology & Urology · 124d
Cleared Nov 19, 1986
MALE URINARY STRESS PAD*
K862877 · EYQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 112d
Cleared Nov 19, 1986
FREE & ACTIVE(TM) ABSORBENT PADS
K862878 · EYQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 112d
Cleared Nov 19, 1986
MENTOR ALLOPLASTIC SPERMATOCELE
K863565 · LQS
Mentor Corp.
Gastroenterology & Urology · 68d
Cleared Nov 19, 1986
P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG
K863854
Precision Medical Devices, Inc.
Orthopedic · 48d
Cleared Nov 19, 1986
AUSTIN MOORE HIP PROSTHESIS
K863896
Kirschner Medical Corp.
Orthopedic · 43d
Cleared Nov 19, 1986
DENTAL PROPHY CUPS (VARIOUS TYPES)
K864059 · EHK
Mission White Dental, Inc.
Dental · 30d
Cleared Nov 19, 1986
SR-MODEL 230 (MODIFICATION)
K864106 · FRN
Hirata Sangyo Co. USA, Inc.
General Hospital · 29d
Cleared Nov 19, 1986
SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T
K864195 · FLL
Respiratory Support Products, Inc.
General Hospital · 23d
Cleared Nov 19, 1986
DR.500O OPERATING TABLE
K864295 · FQO
Koken Mfg Company, Inc.
General & Plastic Surgery · 19d
Cleared Nov 19, 1986
EFTEKHAR RECHANNELIZATION DRILL GUIDE
K864314 · HSZ
The Anspach Effort, Inc.
Orthopedic · 16d
Cleared Nov 19, 1986
DR7700 OPERATING TABLE
K864325 · FQO
Koken Mfg Company, Inc.
General & Plastic Surgery · 16d
Cleared Nov 19, 1986
SECONDARY SET LOCK
K864338 · FPA
Travenol Laboratories, S.A.
General Hospital · 15d
Cleared Nov 19, 1986
LUTEX HEADLIGHT SYSTEMS
K864380 · FST
Luxtec Corp.
General & Plastic Surgery · 14d
Cleared Nov 19, 1986
LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS
K864384 · GAD
Luxtec Corp.
General & Plastic Surgery · 14d
Cleared Nov 18, 1986
MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
K860801 · GWE
Cadwell Laboratories, Inc.
Neurology · 259d
Cleared Nov 18, 1986
FORTEC MI-100, BLOOD PRESSURE METER
K862200 · DSK
Fortec Electronic Corp./Nam Tai
Cardiovascular · 161d
Cleared Nov 18, 1986
MODEL 8 EEG PREAMPLIFIER
K863124 · GWQ
Micro Tronics Corp.
Neurology · 96d
Cleared Nov 18, 1986
MODIFIED SARNS OXYGENATOR SYSTEM
K863515 · DTZ
3M Health Care, Sarns
Cardiovascular · 69d
Cleared Nov 18, 1986
STOCKERT-SHILEY CAPS HLM INTERFACE
K863541 · DTQ
Shiley, Inc.
Cardiovascular · 68d