Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results

70465–70488 of 176,076

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

Cleared Dec 29, 2003

VACUETTE QUICKSHIELD SAFETY TUBE HOLDER

Greiner Bio-One Vacuette North America

General Hospital · 56d

Cleared Dec 29, 2003

BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100

Bruno Independent Living Aids, Inc.

Physical Medicine · 20d

Cleared Dec 24, 2003

SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND...

Surgical Instruments Service and...

General & Plastic Surgery · 190d

Cleared Dec 24, 2003

TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

Gen-Probe, Inc.

Microbiology · 159d

Cleared Dec 24, 2003

IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA

Immco Diagnostics, Inc.

Immunology · 126d

Cleared Dec 24, 2003

APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4

Transphoton Corporation

Radiology · 90d

Cleared Dec 24, 2003

VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS

Varian Medical Systems

Radiology · 64d

Cleared Dec 24, 2003

STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI

Dade Behring, Inc.

Chemistry · 50d

Cleared Dec 24, 2003

PORTASCAN BLADDER SCANNER, MODEL PA00146

Radiology · 7d

Cleared Dec 23, 2003

RANDOX EVIDENCE

Randox Laboratories, Ltd.

Chemistry · 323d

Cleared Dec 23, 2003

STERICHEK BICARB PH REAGENT STRIPS

Environmental Test Systems, Inc.

Gastroenterology & Urology · 246d

Cleared Dec 23, 2003

3D Line USA, Inc.

Radiology · 245d

Cleared Dec 23, 2003

INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS

Intra-Lock International

Cleared Dec 23, 2003

DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)

Chf Solutions, Inc.

Gastroenterology & Urology · 204d

Cleared Dec 23, 2003

DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH,...

Spire Biomedical, Inc.

Gastroenterology & Urology · 173d

Cleared Dec 23, 2003

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

Chroma Vision Medical Systems, Inc.

Pathology · 167d

Cleared Dec 23, 2003

HEPARIN LOCK FLUSH SYRINGE

General Hospital · 140d

Cleared Dec 23, 2003

CLINITEST HCG PREGNANCY TEST

Bayer Healthcare, LLC

Chemistry · 125d

Cleared Dec 23, 2003

INTERMITTENT URETHRAL CATHETERS

Gastroenterology & Urology · 88d

Cleared Dec 23, 2003

DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST

American Green Dent. Mfg, Inc.

Cleared Dec 23, 2003

SUBTALAR PEG IMPLANT

Nexa Orthopedics, Inc.

Orthopedic · 85d

Cleared Dec 23, 2003

UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC,...

Richard Wolf Medical Instruments Corp.

Obstetrics & Gynecology · 84d

Cleared Dec 23, 2003

TRILOGY RADIOTHERAPY DELIVERY SYSTEM

Varian Medical Systems, Inc.

Radiology · 67d

Cleared Dec 23, 2003

DIAZYME LITHIUM ENZYMATIC ASSAY KIT

General Atomics

Chemistry · 63d