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

72529–72552 of 175,468

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

Cleared Mar 27, 2003

QUANTA LITE H.PYLORI IGA ELISA

Inova Diagnostics, Inc.

Microbiology · 91d

Cleared Mar 27, 2003

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE

Genzyme Biosurgery

General & Plastic Surgery · 65d

Cleared Mar 27, 2003

ORG@NIZER, MODEL VERSION 3.0

Ebit Sanita, S.P.A.

Radiology · 51d

Cleared Mar 27, 2003

OTI SCAN WITH TRANSDUCERS

Ophthalmic Technologies, Inc.

Radiology · 16d

Cleared Mar 27, 2003

NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN

Cleared Mar 26, 2003

LOGOS JUNIOR DENTAL CHAIR AND UNIT

Castellini S.P.A.

Cleared Mar 26, 2003

Pentron Clinical Technologies

Cleared Mar 26, 2003

THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE

Cleared Mar 26, 2003

BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS

Microbiology · 93d

Cleared Mar 26, 2003

DENTAL PROTECTOR

Dental Concepts, LLC

Cleared Mar 26, 2003

CLEARFIL SILANE KIT

Kuraray Medical, Inc.

Cleared Mar 26, 2003

Micro Health Systems, Inc.

Radiology · 83d

Cleared Mar 26, 2003

MODIFICATION TO EXPORT ASPIRATION CATHETER

Medtronic Vascular

Cardiovascular · 64d

Cleared Mar 26, 2003

GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE

Pt. Wrp Buana Multicorpora

General Hospital · 58d

Cleared Mar 26, 2003

Wieland Dental + Technik GmbH & Co. KG

Cleared Mar 26, 2003

SPI ELEMENT DENTAL IMPLANT O 3.5 MM

Thommen Medical AG

Cleared Mar 26, 2003

CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL

Cliniqa Corporation

Chemistry · 20d

Cleared Mar 26, 2003

DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM

Diagnostic Ultrasound Corp.

Radiology · 15d

Cleared Mar 26, 2003

AMSCO CENTURY STEAM STERILIZER

STERIS Corporation

General Hospital · 14d

Cleared Mar 25, 2003

LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100

Levitronix, LLC

Cardiovascular · 421d

Cleared Mar 25, 2003

STERILIZATION CASES AND TRAYS

Carr Metal Products, Inc.

General Hospital · 145d

Cleared Mar 25, 2003

VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E

Arista Latindo Industrial Ltd. P.T

General Hospital · 137d

Cleared Mar 25, 2003

VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E

Arista Latindo Industrial Ltd. P.T

General Hospital · 139d

Cleared Mar 25, 2003

REACTIVE SKIN DECONTAMINATION LOTION

Dept. of the Army

General Hospital · 116d