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
149665–149688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1985
WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD
K850726 · IWA
Syncor Intl. Corp.
Radiology · 32d
Cleared Mar 26, 1985
SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY
K850787 · CGI
Nms Pharmaceuticals, Inc.
Chemistry · 28d
Cleared Mar 25, 1985
TBI TRAINER
K840837 · FEJ
Manico
Gastroenterology & Urology · 395d
Cleared Mar 25, 1985
UTAH DISPOSABLE PRESSURE TRANSDUCER
K841788 · DRS
Utah Medical Products, Inc.
Cardiovascular · 329d
Cleared Mar 25, 1985
PRESSURE MONITORING KIT
K842352 · DRS
Utah Medical Products, Inc.
Cardiovascular · 283d
Cleared Mar 25, 1985
LIMI ALLOY
K844653 · EJJ
G-C Intl. Corp.
Dental · 116d
Cleared Mar 25, 1985
KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI
K844662 · EBF
Kerr Corporation (Danbury)
Dental · 115d
Cleared Mar 25, 1985
RESUSCITATOR, PULMONARY, MANUAL
K844729 · BTM
Life Design Systems, Inc.
Anesthesiology · 111d
Cleared Mar 25, 1985
ESPE KETAC-CEM RADIOPAQUE
K844846 · EMA
Espe GmbH (Us)
Dental · 102d
Cleared Mar 25, 1985
STORZ/URBAN SURGICAL MICROSCOPE SYSTEM
K844858 · EPT
Storz Instrument Co.
General & Plastic Surgery · 101d
Cleared Mar 25, 1985
DUALLOR R SOLDER
K844867 · EJT
Degussa Dental, Inc.
Dental · 101d
Cleared Mar 25, 1985
BODY HEARING AIDS MT 80 SP
K850185 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
BOSCH STARR 66PP -HEARING AIDS
K850187 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
BOSCH STAR 66PP-S HEARING AID
K850189 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
STAR 66F-AGC-I HEARING AID
K850190 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
HEARING AID 365
K850243 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 62d
Cleared Mar 25, 1985
PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY
K850263 · BSJ
Plasmedics, Inc.
Anesthesiology · 61d
Cleared Mar 25, 1985
EMERGENCY ROOM PACK
K850338
Marwood Medical, Inc.
General & Plastic Surgery · 56d
Cleared Mar 25, 1985
AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG
K850344 · EGS
Midwest
Dental · 56d
Cleared Mar 25, 1985
AUTOMATIC IMPEDANCE METER TA-7A
K850461 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 47d
Cleared Mar 25, 1985
MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL
K850597 · EFB
Micro-Aire Surgical Instruments, Inc.
Dental · 38d
Cleared Mar 25, 1985
CURAY JOIN DENT DENTIN PRIMER
K850675 · EBD
Scientific Pharmaceuticals, Inc.
Dental · 32d
Cleared Mar 25, 1985
SAF T FLO VENTILATOR TUBING
K850703 · BZO
Bivona Medical Technologies
Anesthesiology · 32d
Cleared Mar 25, 1985
CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL
K850724 · KZI
Rapid City Regional Hospital, Inc.
Microbiology · 31d