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
136897–136920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 09, 1988
PERMADYNE ADHESIVE
K875228 · EBH
Espe GmbH (Us)
Dental · 78d
Cleared Mar 09, 1988
IMPREGUM F ADHESIVE
K875257 · EBH
Espe GmbH (Us)
Dental · 78d
Cleared Mar 09, 1988
LAKE CATHETER CARE KITS (MODIFICATION)
K875383 · KOD
Lake Medical Products, Inc.
Gastroenterology & Urology · 85d
Cleared Mar 09, 1988
MEMORYMATE HEARING AID MODEL 8200
K880082 · ESD
3M Company
Ear, Nose, Throat · 57d
Cleared Mar 09, 1988
CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION
K880169 · LLZ
Cemax, Inc.
Radiology · 54d
Cleared Mar 09, 1988
BEAVERS' DENTAL DIAMOND INSTRUMENTS
K880179 · DZP
Beavers Dental, Div. Sybron Canada, Ltd.
Dental · 56d
Cleared Mar 09, 1988
VIBRASOUND IN-THE-EAR HEARING AID
K880184 · ESD
Vibrasound Research Corp.
Ear, Nose, Throat · 54d
Cleared Mar 09, 1988
MAGIC EAR MODEL CI IN-THE-EAR HEARING AID
K880225 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 09, 1988
PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS
K880283 · DXH
Paceart, Inc.
Cardiovascular · 47d
Cleared Mar 09, 1988
MOBILE C-ARM OMNI 325
K880518 · OXO
Fischer Imaging Corp.
Radiology · 29d
Cleared Mar 09, 1988
SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
K880614 · BTO
Shiley, Inc.
Anesthesiology · 22d
Cleared Mar 09, 1988
IN THE EAR HEARING AID
K880635 · ESD
Tallahassee Hearing Aid Center
Ear, Nose, Throat · 22d
Cleared Mar 09, 1988
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
K880664 · DSI
Mortara Instrument, Inc.
Cardiovascular · 20d
Cleared Mar 09, 1988
KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT
K880683 · CAI
King Systems Corp.
Anesthesiology · 19d
Cleared Mar 08, 1988
O.P.C. INTRAVASCULAR CATHETER
K875082 · FOZ
Taut, Inc.
General Hospital · 90d
Cleared Mar 08, 1988
MENTOR B-VAT(TM) II VIDEO TESTER
K875112 · HOX
Mentor O & O, Inc.
Ophthalmic · 84d
Cleared Mar 08, 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS
K880024 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 63d
Cleared Mar 08, 1988
NUTRIENT BROTH
K880114 · JSG
Hardy Media
Microbiology · 62d
Cleared Mar 08, 1988
NUTRIENT GELATIN
K880115 · JSF
Hardy Media
Microbiology · 62d
Cleared Mar 08, 1988
DYNATRON II
K880464 · LBB
Dynatronics Laser Corp.
Neurology · 34d
Cleared Mar 07, 1988
ACRYLIC IMPRESSION TRAY MATERIALS
K873739 · EBH
E&D Dental Manufacturing Co.
Dental · 174d
Cleared Mar 07, 1988
DISPOSABLE INFUSION CANNULA 0045-1/2/3 2.5/4.0/6.0
K873853 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 167d
Cleared Mar 07, 1988
SIMED S-100 PULSE OXIMETER
K873896 · DQA
Simed
Anesthesiology · 187d
Cleared Mar 07, 1988
MONITOR, ELECTROGRAPHIC
K874319 · DRT
Medac, Inc.
Cardiovascular · 138d