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
122881–122904 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 1991
ROMFLEX REHAB EQUIP EXTREMITIES UNIT
K910150 · BXB
Dyna Flex, Intl.
Physical Medicine · 9d
Cleared Jan 22, 1991
AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT
K903808 · IZG
Advanced Med/Surg, Inc.
Radiology · 155d
Cleared Jan 22, 1991
VIDEO OTOSCOPE
K904802 · ERA
Jedmed Instrument Co.
Ear, Nose, Throat · 90d
Cleared Jan 22, 1991
STORZ DRAEGER ROTOR KERATOME
K904845 · HNO
Storz Instrument Co.
Ophthalmic · 89d
Cleared Jan 22, 1991
MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS
K905207 · IME
Micro Surgical Instruments Corp.
Physical Medicine · 63d
Cleared Jan 22, 1991
GENERAL MEDICAL PROCEDURE KIT/SKIN PREPARATION
K905463 · FOZ
Angiosystems, Inc.
General Hospital · 48d
Cleared Jan 18, 1991
MODEL T11 FLUIDOTHERAPY UNIT
K896817 · LSB
Henley Intl.
Physical Medicine · 410d
Cleared Jan 18, 1991
BIFLEX(TM) ANNULOPLASTY RING
K902159 · KRH
St. Jude Medical, Inc.
Cardiovascular · 248d
Cleared Jan 18, 1991
SERIES 1500 RESPONDER
K902782 · LDD
Marquette Electronics, Inc.
Cardiovascular · 206d
Cleared Jan 18, 1991
OMRON OSCILLOMETRIC DIGITAL BP MONITOR-HEM-405C
K903133 · DXN
Omron Marshall Products, Inc.
Cardiovascular · 185d
Cleared Jan 18, 1991
ARZO TAPCATH ESOPHAGEAL RECORDING CATHETER
K903136 · DRF
Arzco Medical Electronics, Inc.
Cardiovascular · 185d
Cleared Jan 18, 1991
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
K903186 · DXY
Telectronics Pacing Systems, Inc.
Cardiovascular · 183d
Cleared Jan 18, 1991
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638 · LIO
Medical Laboratory Automation...
Microbiology · 158d
Cleared Jan 18, 1991
SYNAPS (TM)
K903828 · GZJ
Henley Intl.
Neurology · 150d
Cleared Jan 18, 1991
MTS FEMORAL HIP SYSTEM
K903877 · KWL
3M Company
Orthopedic · 149d
Cleared Jan 18, 1991
COMPACT MONITOR SMK 210,211,230,231,240
K903917 · DSP
Ppg Hellige B.V.
Cardiovascular · 147d
Cleared Jan 18, 1991
VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER
K904222 · GWL
Telediagnostic Systems, Inc.
Neurology · 127d
Cleared Jan 18, 1991
FREE PROTEIN S REAGENT CAT. NO. 5363
K904247 · GGP
Helena Laboratories
Hematology · 126d
Cleared Jan 18, 1991
FOCUS T41,T41F,T43, T43F,T44F
K904255 · DTB
Elamedical
Cardiovascular · 123d
Cleared Jan 18, 1991
KODAK SURECELL(TM) STREP A CONTROL FLUID SET
K904589 · GTY
Eastman Kodak Company
Microbiology · 101d
Cleared Jan 18, 1991
BUTTON REPLACEMENT GASTROSTOMY DEVICE
K904779 · KGC
C.R. Bard, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 18, 1991
OPTEC 2300 AFVT, ARMED FORCES VISION TESTER
K904828 · HKO
Stereo Optical Co., Inc.
Ophthalmic · 86d
Cleared Jan 18, 1991
PATIENT EXAMINATION GLOVES
K905031 · LYZ
Phoenix Medical Technology, Inc.
General Hospital · 72d
Cleared Jan 18, 1991
COMFORT SLEEVED ALL SILICONE FOLEY CATHETER
K905042 · EZL
Rochester Medical Corp.
Gastroenterology & Urology · 72d