FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
147961–147984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1985
DEKNATEL THORACIC CATHETER
K852041 · JOL
Pfizer, Inc.
General Hospital · 39d
Cleared Jun 17, 1985
MERIVAARA CRIB TROLLEY-MODEL 381
K852173 · FMS
Daun International, Inc.
General Hospital · 28d
Cleared Jun 14, 1985
AMBULATORY PH RECORDING DEVICE
K842349 · DSH
Clinical Data Instruments, Inc.
Cardiovascular · 364d
Cleared Jun 14, 1985
PHOENIX ANESTHESIA MACHINE
K844563 · BSZ
American Anesthesia, Inc.
Anesthesiology · 205d
Cleared Jun 14, 1985
RESP-BAC BACTERIA FILTER
K851070 · CAH
Medicomp, Inc.
General Hospital · 88d
Cleared Jun 14, 1985
ANESTHESIA BREATHING CIRCUIT
K851193 · CAI
Avatron, Inc.
Anesthesiology · 80d
Cleared Jun 14, 1985
DESERET ARTERIAL CATHETER
K851327 · FOZ
Parke-Davis Co.
General Hospital · 71d
Cleared Jun 14, 1985
VYGON BALLOON FOR IDENTIFICATION OF EPIDURAL 193
K851479 · CAZ
Vygon Corp.
Anesthesiology · 60d
Cleared Jun 14, 1985
GASTROINTESTINAL TUBE
K851671 · KNT
Sheridan Catheter Corp.
Gastroenterology & Urology · 52d
Cleared Jun 14, 1985
DIGITAL GAMMA CAMERA GCA 601 E
K851685 · JWM
Toshiba Medical Systems
Radiology · 52d
Cleared Jun 14, 1985
880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR
K851717 · EMJ
Artiberia
Dental · 50d
Cleared Jun 14, 1985
COMPACT 2000
K851892 · KDQ
Atrium Medical Corp.
General Hospital · 45d
Cleared Jun 14, 1985
CORNING CERTAIN -ISE
K851939 · JIX
Corning Medical & Scientific
Chemistry · 42d
Cleared Jun 14, 1985
PENNINE OXYGEN LINK TUBING
K852081 · BYX
Pennine Medical , Ltd.
Anesthesiology · 32d
Cleared Jun 14, 1985
AXIOM ATRAUM TROCAR CATHETER
K852241 · GBS
Axiom Medical, Inc.
General & Plastic Surgery · 22d
Cleared Jun 14, 1985
STAND, OPERATING ROOM
K852329 · FOX
Scholten Surgical Instruments, Inc.
General Hospital · 14d
Cleared Jun 13, 1985
ROTAVIRUS ENZYME IMMUNOASSAY
K843367 · LIQ
Intl. Diagnostic Laboratories, Ltd.
Immunology · 289d
Cleared Jun 13, 1985
NEURO CUSTOM SURGICAL KIT
K844594 · HBA
Xanmed Corp.
Neurology · 199d
Cleared Jun 13, 1985
BUSHEL OFF-HEAD PREAMPLIFIER
K850418 · GWQ
Oxford Medilog, Inc.
Neurology · 129d
Cleared Jun 13, 1985
SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE
K850778 · FFT
Settler Medical Electronics, Inc.
Gastroenterology & Urology · 107d
Cleared Jun 13, 1985
SHARP DIGITAL BP MONITOR MB-371H
K850830 · DXN
Sharp Electronics Corp.
Cardiovascular · 127d
Cleared Jun 13, 1985
GRAVITY KING (DEEMED SE 87/09/18)
K851065 · ION
Unique Functional Products
Physical Medicine · 90d
Cleared Jun 13, 1985
TECA MONTAGE II
K851232 · GWQ
Teca, Inc.
Neurology · 79d
Cleared Jun 13, 1985
NEUROPACK 8, MEE-4108
K851300 · GWF
Nihon Kohden America, Inc.
Neurology · 73d