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

Filters: Cleared only ×
175,820 results
99505–99528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1996
NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
K955778 · HRY
Intermedics Orthopedics
Orthopedic · 79d
Cleared Mar 08, 1996
PERCUTANEOUS ENDOSCOPIC DISCECTOMY
K960222 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 52d
Cleared Mar 08, 1996
INTERPORE THREADED IMPLANT
K960371 · DZE
Interpore Intl.
Dental · 42d
Cleared Mar 08, 1996
POS-T-VAC B-10 BAND KIT
K960828 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 8d
Cleared Mar 07, 1996
ULTRA EASE
K950943 · IYO
Lectec Corp.
Radiology · 385d
Cleared Mar 07, 1996
TREATMENT MANAGEMENT SYSTEM
K953391 · LHN
Siemens Medical Solutions USA, Inc.
Radiology · 232d
Cleared Mar 07, 1996
BIOCOR 200 HARDSHELL VENOUS RESERVIOR
K953821 · DTN
Minntech Corp.
Cardiovascular · 205d
Cleared Mar 07, 1996
AESCULAP VENTRICULOSCOPE SYSTEM
K954394 · GWG
Aesculap, Inc.
Neurology · 171d
Cleared Mar 07, 1996
VS-200 VIDEO SIGMOIDOSCOPE
K954704 · FDF
Welch Allyn, Inc.
Gastroenterology & Urology · 147d
Cleared Mar 07, 1996
DISPOSABLE NEUROVIEW OPERATING SHEATH
K954938 · GWG
Neuro Navigational Corp.
Neurology · 129d
Cleared Mar 07, 1996
AXSYM PROGESTERONE
K955025 · JLS
Abbott Laboratories
Chemistry · 126d
Cleared Mar 07, 1996
JETSTREAM CAVITY PREPARATION SYSTEM
K955050 · KOJ
Dove Systems, Inc.
Dental · 125d
Cleared Mar 07, 1996
TRUZONE PEAK FLOW METER
K955262 · BZH
Monaghan Medical Corp.
Anesthesiology · 114d
Cleared Mar 07, 1996
VASCUTEK GRAFT SIZER SET
K955588 · DSY
Carbomedics, Inc.
Cardiovascular · 91d
Cleared Mar 07, 1996
AUDIOFLEX 120
K960031 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 65d
Cleared Mar 07, 1996
UNITRON MODEL SOUND F/XP
K960155 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 56d
Cleared Mar 07, 1996
RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
K960229 · ETW
Resound Corp.
Ear, Nose, Throat · 50d
Cleared Mar 07, 1996
OTICON /PRIMOFOCUS (PF)
K960284 · ESD
Oticon, Inc.
Ear, Nose, Throat · 48d
Cleared Mar 07, 1996
FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM
K960326 · LMB
Fujifilm Medical System U.S.A., Inc.
Radiology · 43d
Cleared Mar 07, 1996
AESCULAP POWER SYSTEM HANDPIECE
K960473 · GET
Aesculap, Inc.
General & Plastic Surgery · 35d
Cleared Mar 06, 1996
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458 · CHH
Boehringer Mannheim Corp.
Chemistry · 541d
Cleared Mar 06, 1996
SSC MODEL 4000 SERIES
K951514 · FNL
Ssc Medical Products, Inc.
General Hospital · 338d
Cleared Mar 06, 1996
MYOCARDIAL PROTECTION SYSTEM
K953838 · DTR
Quest Medical, Inc.
Cardiovascular · 203d
Cleared Mar 06, 1996
MEDICOOL (MODIFICATON)
K954095 · ILO
Microclimate Systems, Inc.
Physical Medicine · 199d