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
121585–121608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1991
SOREX SAFE-AIR
K911150 · GEX
Sorex Medical
General & Plastic Surgery · 105d
Cleared Jun 28, 1991
VLC GLASS IONOMER LINER
K911244 · EJK
Dentsply Intl.
Dental · 99d
Cleared Jun 28, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY
K911276 · LNH
Toshiba America Mri, Inc.
Radiology · 95d
Cleared Jun 28, 1991
LIMA CEMENT RESTRICTOR
K911338 · JDK
Turnkey Intergration USA, Inc.
Orthopedic · 94d
Cleared Jun 28, 1991
PS MEDICAL BUTTON VALVE
K911410 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 88d
Cleared Jun 28, 1991
OLYMPUS DISPOSABLE BIOPSY VALVE
K911412 · EOQ
Olympus Corp.
Ear, Nose, Throat · 88d
Cleared Jun 28, 1991
HISTOFREEZER
K911420 · GEH
Solarcare Technologies Corp,Inc.
General & Plastic Surgery · 88d
Cleared Jun 28, 1991
FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM
K911445 · JDR
Neoligaments, Ltd.
Orthopedic · 86d
Cleared Jun 28, 1991
ISOLA(TM) SPINE SYSTEM - ILIAC SCREW
K911528 · KWP
Acromed Corp.
Orthopedic · 85d
Cleared Jun 28, 1991
ACRYL-X SYSTEM TM
K911548 · JDX
Sonokinetics, Inc.
Orthopedic · 81d
Cleared Jun 28, 1991
ANATOMIC TOE SYSTEM
K911552 · LZJ
Orthopaedic Biosystems
Orthopedic · 81d
Cleared Jun 28, 1991
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
K911613 · LCR
Exmoor Plastics , Ltd.
Toxicology · 86d
Cleared Jun 28, 1991
CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
K911703 · DQO
Cordis Corp.
Cardiovascular · 73d
Cleared Jun 28, 1991
PHILIPS TELESCAN
K911773 · LMD
Philips Medical Systems, Inc.
Radiology · 70d
Cleared Jun 28, 1991
MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
K911806 · LNH
General Electric Co.
Radiology · 66d
Cleared Jun 28, 1991
TEMPERLITE(TM) SAW BLADE
K911902 · HSD
Sierra Surgical, Inc.
Orthopedic · 63d
Cleared Jun 28, 1991
MAXI-SCOPE OR ULTRA-SCOPE
K912128 · LDE
Seiichi Mfg., Inc.
Cardiovascular · 45d
Cleared Jun 28, 1991
OLDELFT SIMULIX-MC
K912466 · KPQ
Oldelft Corp. of America
Radiology · 24d
Cleared Jun 27, 1991
ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A
K905569 · GZB
Biomedical Life Systems, Inc.
Neurology · 197d
Cleared Jun 27, 1991
KEANE UNI KNEE SYSTEM
K910807 · HSX
Depuy, Inc.
Orthopedic · 121d
Cleared Jun 27, 1991
NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER
K910890 · LYU
Lovell-Schenck, Inc.
General Hospital · 128d
Cleared Jun 27, 1991
INERPAN(TM) TEMPORARY WOUND DRESSING
K911161 · MGP
Laboratories Delalande
General & Plastic Surgery · 104d
Cleared Jun 27, 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · HWC
Howmedica Corp.
Orthopedic · 90d
Cleared Jun 27, 1991
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
K911628 · LIF
Serim Research Corp.
Gastroenterology & Urology · 77d