FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

175,468 results

70369–70392 of 175,468

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

Cleared Nov 05, 2003

MEDIC COLON MODEL, RELEASE 1

Radiology · 37d

Cleared Nov 05, 2003

WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347,...

Hand Biomechanics Lab, Inc.

Orthopedic · 36d

Cleared Nov 05, 2003

HOFFMANN II PELVIC CLAMP

Howmedica Osteonics Corp.

Orthopedic · 36d

Cleared Nov 05, 2003

SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES

Orthopedic · 36d

Cleared Nov 05, 2003

HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER

Radiology · 30d

Cleared Nov 05, 2003

LACTOSORB TIBIAL L-15 SCREW AND WASHER

Orthopedic · 30d

Cleared Nov 05, 2003

MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM

Cardiovascular · 29d

Cleared Nov 05, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK

Ortho-Clinical Diagnostics, Inc.

Chemistry · 22d

Cleared Nov 05, 2003

SELECTIVA SB GUIDEWIRE

Neometrics, Inc.

Cardiovascular · 21d

Cleared Nov 05, 2003

VIATRONIX V3D VASCULAR, REVISION 1.0

Viatronix, Inc.

Radiology · 15d

Cleared Nov 05, 2003

TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS...

Radiology · 15d

Cleared Nov 05, 2003

SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP...

Medtronic Perfusion Systems

Cardiovascular · 9d

Cleared Nov 04, 2003

THERATEARS CONTACT LENS COMFORT DROPS

Advanced Vision Research, Inc.

Ophthalmic · 84d

Cleared Nov 04, 2003

Cleared Nov 04, 2003

VITEK 2 GRAM NEGATIVE GATIFLOXACIN

bioMerieux, Inc.

Microbiology · 57d

Cleared Nov 04, 2003

Microbiology · 25d

Cleared Nov 04, 2003

HYDRAGEL CSF ISOFOCUSING KITS

Immunology · 25d

Cleared Nov 04, 2003

COLIBRI DISPOSABLE VITRECTOMY CUTTER

Microworld Medical Instruments, Inc.

Ophthalmic · 12d

Cleared Nov 03, 2003

ATAC HEMOGLOBIN A1C REAGENT KIT

Clinical Data, Inc.

Chemistry · 216d

Cleared Nov 03, 2003

OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM

Cleared Nov 03, 2003

EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE

Edwards Lifesciences, LLC

Cardiovascular · 132d

Cleared Nov 03, 2003

Coltene/Whaledent GmbH & Co. KG

Cleared Nov 03, 2003

BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT)

Lin-Zhi International, Inc.

Toxicology · 59d

Cleared Nov 03, 2003

CRYOCHECK WEAK LUPUS POSITIVE CONTROL

Precision Biologic

Hematology · 55d