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

72097–72120 of 174,955

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

Cleared Mar 20, 2003

OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM

Ge Oec Medical Systems

Radiology · 106d

Cleared Mar 20, 2003

ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475

Orthopedic · 86d

Cleared Mar 20, 2003

ENHANCE SPERM FREEZE

Conception Technology, Inc.

Obstetrics & Gynecology · 66d

Cleared Mar 20, 2003

MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6,...

Avail Medical Products, Inc.

General Hospital · 64d

Cleared Mar 20, 2003

POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE

Kaohsiung Brothers Products Corp.

General Hospital · 58d

Cleared Mar 20, 2003

GENICON CLIP APPLIER

General & Plastic Surgery · 52d

Cleared Mar 20, 2003

KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW

KARL STORZ Endoscopy-America, Inc.

Orthopedic · 44d

Cleared Mar 20, 2003

STRYKER LEIBINGER CRANIAL FIXATION SYSTEM

Stryker Instruments

Neurology · 43d

Cleared Mar 20, 2003

PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03

Ethicon Endo-Surgery, Inc.

General & Plastic Surgery · 41d

Cleared Mar 20, 2003

Orthopedic · 29d

Cleared Mar 20, 2003

X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS

Orthopedic · 29d

Cleared Mar 20, 2003

DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B

Well-Life Healthcare, Inc.

Neurology · 28d

Cleared Mar 20, 2003

SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES

Orthopedic · 23d

Cleared Mar 20, 2003

EVA DIGITAL DENTAL X-RAY SYSTEM

Afp Imaging Corp.

Radiology · 20d

Cleared Mar 20, 2003

AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV

Neurology · 14d

Cleared Mar 20, 2003

EBI DYNAFIX COMPRESSION BONE SCREW

Orthopedic · 14d

Cleared Mar 20, 2003

INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3

Physical Medicine · 6d

Cleared Mar 19, 2003

OPTION-VF URINARY CATHETER, FV14218

Opticon Medical, Inc.

Gastroenterology & Urology · 183d

Cleared Mar 19, 2003

CHROMOCHECK PROTEIN C 25

Precision Biologic

Hematology · 106d

Cleared Mar 19, 2003

SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

Spectral Diagnostics, Inc.

Chemistry · 71d

Cleared Mar 19, 2003

HEMOSIL FACTOR XI DEFICIENT PLASMA

Instrumentation Laboratory CO

Hematology · 50d

Cleared Mar 19, 2003

WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553

Wiener Laboratories

Chemistry · 34d

Cleared Mar 19, 2003

IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM

Medtronic Surgical Navigation...

Neurology · 26d

Cleared Mar 19, 2003

ATAC CALIBRATOR

Elan Diagnostics

Chemistry · 20d