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
74401–74424 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2002
BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS
K021057 · MSW
Brahms Diagnostica, LLC
Immunology · 169d
Cleared Sep 17, 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761 · KWQ
Medtronic Sofamor Danek
Orthopedic · 111d
Cleared Sep 17, 2002
OEC FLUOROTRAK 9800 PLUS
K022069 · OWB
Ge Oec Medical Systems
Radiology · 84d
Cleared Sep 17, 2002
IMPERIUM
K022114 · OWB
Elmstech, Inc.
Radiology · 81d
Cleared Sep 17, 2002
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506
K022163 · DQA
Welch Allyn, Inc.
Anesthesiology · 76d
Cleared Sep 17, 2002
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
K022324 · HRS
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 17, 2002
POCKETCHEM UA AUTION STICKS 10TA
K022386 · JIL
Arkray, Inc.
Chemistry · 57d
Cleared Sep 17, 2002
EXTERNAL FIXATION RING
K022423 · KTT
Rigid FX Orthopedics, Incorporated
Orthopedic · 55d
Cleared Sep 17, 2002
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA
K022444 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 54d
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