FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
107257–107280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1994
IMPLEX CEMENT RESTRICTOR SYSTEM
K943378 · LZN
Implex Corp.
Orthopedic · 72d
Cleared Sep 23, 1994
INTERACOUSTICS HEARING AID ANALYZER MS 40
K943607 · ETW
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 60d
Cleared Sep 23, 1994
PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
K943805 · JAA
General Electric Co.
Radiology · 50d
Cleared Sep 23, 1994
MIRACLE-EAR MIRAGE
K943826 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 23, 1994
FORCE GSU-SLPM SYSTEM
K943865 · GEI
Valleylab, Inc.
General & Plastic Surgery · 46d
Cleared Sep 23, 1994
VIDEO SCOPE SYSTEM (OTOSCOPE)
K944031 · ERA
Jedmed Instrument Co.
Ear, Nose, Throat · 37d
Cleared Sep 23, 1994
ORIGIN BALLOON ANCHOR
K944304 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 21d
Cleared Sep 22, 1994
MODEL 7200AE VENTILATOR
K922705 · CBK
Puritan Bennett Corp.
Anesthesiology · 839d
Cleared Sep 22, 1994
MODEL 7200AE VENTILATOR (ENHANCEMENT)
K922975 · CBK
Puritan Bennett Corp.
Anesthesiology · 822d
Cleared Sep 22, 1994
AUTO-PEEP
K924043 · CBK
Puritan Bennett Corp.
Anesthesiology · 772d
Cleared Sep 22, 1994
7250 METABOLIC MONITOR
K924978 · BZL
Puritan Bennett Corp.
Anesthesiology · 721d
Cleared Sep 22, 1994
PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD
K930017 · CBK
Puritan Bennett Corp.
Anesthesiology · 626d
Cleared Sep 22, 1994
GERITREX STERILE SALINE SOLUTION FOR IRRIGATION
K931509 · JOL
Geritrex Corp.
General Hospital · 545d
Cleared Sep 22, 1994
CARDIAC CATHETERIZATION KIT
K932141 · DQO
Abbott Laboratories
Cardiovascular · 518d
Cleared Sep 22, 1994
CYTOGUIDE STEREOTATIC BIOPSY SYSTEM
K933430 · IZH
Gold Coast Imaging, Inc.
Radiology · 436d
Cleared Sep 22, 1994
PM-PAGER
K933552 · KMI
Hill Engineering
General Hospital · 428d
Cleared Sep 22, 1994
HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION
K934041 · IYN
Hewlett-Packard Co.
Radiology · 399d
Cleared Sep 22, 1994
CLOTH TENS/BNES ELECTRODE
K942718 · GXY
Conmed Andover Medical, Inc.
Neurology · 105d
Cleared Sep 22, 1994
ADVANCED IN-BED WEIGH SYSTEM
K943587 · FRW
Future Systems, Inc.
General Hospital · 62d
Cleared Sep 21, 1994
REGIONAL ANAESTHESIA TRAY
K932614 · CAZ
Mediziv Medical Products , Ltd.
Anesthesiology · 481d
Cleared Sep 21, 1994
SELF TAPPING DENTAL IMPLANT SYSTEM
K933532 · DZE
Implant Support Systems, Inc.
Dental · 427d
Cleared Sep 21, 1994
IMKB CONTRA-ANGLES
K933639 · EGS
Micro-Mega
Dental · 421d
Cleared Sep 21, 1994
INVAMED REUSABLE LAPAROSCOPIC TROCAR SYSTEM
K936011 · HET
Invamed, Inc.
Obstetrics & Gynecology · 279d
Cleared Sep 21, 1994
3M 1152 LASER IMAGER
K936152 · LMC
3M Information,Imaging and Electronic...
Radiology · 268d