FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90769–90792 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1998
SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE
K974775 · FAP
Airtronic Services, Inc.
Gastroenterology & Urology · 59d
Cleared Feb 19, 1998
RUNCH INDUSTRIAL WHEELCHAIR
K980107 · IOR
Runch Group USA, Inc.
Physical Medicine · 38d
Cleared Feb 18, 1998
PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
K971708 · HCC
J & J Engineering, Inc.
Neurology · 286d
Cleared Feb 18, 1998
STELLAR MODEL HS-04
K973223 · IPF
Stellar Medical Corp.
Physical Medicine · 175d
Cleared Feb 18, 1998
BIOROC EZ SUTURE BONE FASTENER
K973381 · MAI
Innovasive Devices, Inc.
Orthopedic · 163d
Cleared Feb 18, 1998
AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
K973760 · DTZ
Avecor Cardiovascular, Inc.
Cardiovascular · 139d
Cleared Feb 18, 1998
INNOVASIVE LINX BT 10MM LIGAMENT FASTENER
K974049 · MBI
Innovasive Devices, Inc.
Orthopedic · 117d
Cleared Feb 18, 1998
JTECH ADJUSTER REFLEX GUN
K974376 · LXM
J-Tech Medical, Inc.
Physical Medicine · 90d
Cleared Feb 18, 1998
ULTRANEB
K974379 · CAF
Bremed Italia, S.R.L.
Anesthesiology · 90d
Cleared Feb 18, 1998
PULPDENT CAVITY VARNISH
K974398 · LBH
Pulpdent Corp.
Dental · 89d
Cleared Feb 18, 1998
ORTHOPLAN
K974406 · HWT
Ortho-Graphics, Inc.
Orthopedic · 89d
Cleared Feb 18, 1998
RAPET CRP
K974429 · DCN
Stanbio Laboratory
Immunology · 86d
Cleared Feb 18, 1998
SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
K974487 · EIA
Asi Medical, Inc.
Dental · 84d
Cleared Feb 18, 1998
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
K974537 · KTT
Synthes (Usa)
Orthopedic · 77d
Cleared Feb 18, 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K974573 · KWP
Depuy, Inc.
Orthopedic · 72d
Cleared Feb 18, 1998
PERCSCOPE MODEL 2600
K974579 · HRX
Clarus Medical Systems, Inc.
Orthopedic · 72d
Cleared Feb 18, 1998
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
K980226 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 27d
Cleared Feb 18, 1998
ACRI R NEEDLE
K980248 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 26d
Cleared Feb 18, 1998
RELIEFBAND
K980333 · GZJ
Woodside Biomedical, Inc.
Neurology · 21d
Cleared Feb 18, 1998
MANAN LIVER BIOPSY KIT
K980452 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 13d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
K971169 · LSR
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
K971170 · LSR
Cambridge Biotech Corp.
Microbiology · 326d
Cleared Feb 17, 1998
OBSERVER * CENTRAL STATION
K972498 · DSI
Johnson & Johnson Medical, Inc.
Cardiovascular · 229d
Cleared Feb 17, 1998
REGANES RADIONUCLIDE SEED MAGAZINE
K972554 · IWJ
Avid N.I.T., Inc.
Radiology · 224d