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
73897–73920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2002
PORTA IP SOLDER V-1
K022456 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d
Cleared Sep 17, 2002
PORTA OPTIMUM SOLDER 710
K022457 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d
Cleared Sep 17, 2002
PORTA IP SOLDER V-2
K022467 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d
Cleared Sep 17, 2002
PORTA OPTIMUM SOLDER 900
K022468 · EJT
Wieland Dental + Technik GmbH & Co. KG
Dental · 53d
Cleared Sep 17, 2002
BIOMET CALCANEAL PLATE
K022515 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 49d
Cleared Sep 17, 2002
POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E
K022701 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 34d
Cleared Sep 17, 2002
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR THE DADE BN II NEPHELOMETER
K022758 · JJX
Cliniqa Corporation
Chemistry · 28d
Cleared Sep 17, 2002
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
K022772 · MRR
Hemagen Diagnostics, Inc.
Chemistry · 27d
Cleared Sep 17, 2002
MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K022818 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 22d
Cleared Sep 17, 2002
GEN-PROBE APTIMA COMBO 2 ASSAY
K022874 · JTW
Gen-Probe, Inc.
Microbiology · 53d
Cleared Sep 17, 2002
BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)
K022878 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 18d
Cleared Sep 17, 2002
M2376A DEVICELINK SYSTEM
K022920 · MWI
Philips Medical Systems
Cardiovascular · 13d
Cleared Sep 17, 2002
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593
K022991 · JJY
Bio-Rad
Immunology · 8d
Cleared Sep 16, 2002
SANIDAD THERMAL FAR-INFRARED WAVE LAMP, MODEL AP-2018
K020462 · ILY
Rolor Electronics Corp.
Physical Medicine · 216d
Cleared Sep 16, 2002
ULTI GUARD HOME INSULIN SYRINGE CONTAINER
K021983 · MMK
Ultimed, Inc.
General Hospital · 90d
Cleared Sep 16, 2002
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT...
K022343 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 59d
Cleared Sep 16, 2002
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K022600 · LYZ
Shijiazhuang Wally Plastics Co., Ltd.
General Hospital · 42d
Cleared Sep 16, 2002
SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES
K022639 · LYZ
Shijiazhuang Holy Plastics Co., Ltd.
General Hospital · 39d
Cleared Sep 16, 2002
POWDERED SYNTHETIC VINYL EXAM GLOVES
K022702 · LYZ
Shijiazhuang Holy Plastics Co., Ltd.
General Hospital · 33d
Cleared Sep 16, 2002
MODIFICATION TO PLAYTEX TAMPONS #24002
K022882 · HIL
Playtex Products, Inc.
Obstetrics & Gynecology · 17d
Cleared Sep 13, 2002
DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11
K014141 · DXN
Digibio Technology Corp.
Cardiovascular · 270d
Cleared Sep 13, 2002
AB BELT
K020427 · NGX
The Dezac Group
Physical Medicine · 217d
Cleared Sep 13, 2002
AB BELT PRO
K020429 · NGX
The Dezac Group
Physical Medicine · 217d
Cleared Sep 13, 2002
RSV OIA
K021172 · GOG
Thermo Biostar, Inc.
Microbiology · 154d