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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

174,955 results

70945–70968 of 174,955

Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery

Cleared Jul 24, 2003

NOBEL DIRECT, MODELS 30937, 30938

Nobel Biocare Uas, Inc.

Cleared Jul 24, 2003

NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE...

Green Prospect Sdn Bhd

General Hospital · 65d

Cleared Jul 24, 2003

Tinnitus Control, Inc.

Ear, Nose, Throat · 62d

Cleared Jul 24, 2003

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V

Olympus Optical Co., Ltd.

Ear, Nose, Throat · 57d

Cleared Jul 24, 2003

MODIFICATION TO FORTITUDE CEMENT RESTRICTOR

Spinal Concepts, Inc.

Orthopedic · 38d

Cleared Jul 24, 2003

HOFFMANN II COMPACT BALTIMORE COUPLING

Howmedica Osteonics Corp.

Orthopedic · 30d

Cleared Jul 24, 2003

ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS

Ear, Nose, Throat · 27d

Cleared Jul 24, 2003

MODEL J-5 MVO-MONITOR

Myotronics-Noromed, Inc.

Cleared Jul 24, 2003

COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER

Beckman Coulter, Inc.

Hematology · 24d

Cleared Jul 24, 2003

KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60

Cleared Jul 24, 2003

WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A

Wide Corporation

Radiology · 8d

Cleared Jul 23, 2003

HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS,...

Hoffrichter GmbH

Anesthesiology · 590d

Cleared Jul 23, 2003

MODEL 9600, AVANT PULSE OXIMETER

Nonin Medical, Inc.

Anesthesiology · 314d

Cleared Jul 23, 2003

PICOSAT II SPO2 PULSE OXIMETRY MODULE

Philips Medical Systems

Anesthesiology · 117d

Cleared Jul 23, 2003

NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 &...

Needle Tech Products, Inc.

General & Plastic Surgery · 100d

Cleared Jul 23, 2003

Radiology · 97d

Cleared Jul 23, 2003

XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE

Olympus Opto-Electronics Co., Ltd.

Gastroenterology & Urology · 93d

Cleared Jul 23, 2003

MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712

General Hospital · 82d

Cleared Jul 23, 2003

RAPIDO CUT-AWAY CUTTER

Cardiovascular · 76d

Cleared Jul 23, 2003

EMIT II PLUS COCAINE METABOLITE ASSAY

Dade Behring, Inc.

Toxicology · 70d

Cleared Jul 23, 2003

LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS

Cliniqa Corporation

Immunology · 64d

Cleared Jul 23, 2003

CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001

Trans Vascular Incorporated

Radiology · 30d

Cleared Jul 22, 2003

EKOS PERIPHERAL INFUSION SYSTEM

Cardiovascular · 144d

Cleared Jul 22, 2003

VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER

Biosense Webster, Inc.

Cardiovascular · 99d