FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
124729–124752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1990
PEGASUS W/ACCESSORIES FOR GENERAL SURGERY
K902946 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 89d
Cleared Oct 02, 1990
PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION
K902947 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 89d
Cleared Oct 02, 1990
COHERENT HOLMIUM:YAG SURGICAL LASER
K902990 · GEX
Coherent Medical Division
General & Plastic Surgery · 85d
Cleared Oct 02, 1990
PEGASUS WITH ACCESSORIES
K903027 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 84d
Cleared Oct 02, 1990
ELECTRODE, ELECTROSURGERY
K903302 · JOS
Megadyne Medical Products, Inc.
General & Plastic Surgery · 70d
Cleared Oct 02, 1990
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435 · JOH
Shiley, Inc.
Anesthesiology · 63d
Cleared Oct 02, 1990
ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST
K903556 · MDE
Gen-Probe, Inc.
Microbiology · 56d
Cleared Oct 02, 1990
QUIDEL CHLAMYDIA POSITIVE CONTROL
K903765 · LJC
Quidel Corp.
Microbiology · 46d
Cleared Oct 02, 1990
IMMUNODOT THYROID AUTOIMMUNITY PANEL
K903843 · JNL
General Biometrics, Inc.
Chemistry · 42d
Cleared Oct 02, 1990
ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.
K904047 · MDF
Gen-Probe, Inc.
Microbiology · 28d
Cleared Oct 02, 1990
DISCRENE SELF-SUPPORTING BREAST FORM
K904086 · KCZ
Coloplast A/S
General & Plastic Surgery · 27d
Cleared Oct 02, 1990
SUTURE TENSION ADJUSTMENT REEL
K904136 · KGS
Surgical Systems, Inc.
General & Plastic Surgery · 26d
Cleared Oct 02, 1990
BAUMAN CPR/RESUSCITATOR
K904346 · BTM
General Medical Products, Inc.
Anesthesiology · 8d
Cleared Oct 01, 1990
N-A-G TEST KIT
K893582 · CGX
Ppr Diagnostics , Ltd.
Chemistry · 510d
Cleared Oct 01, 1990
ELECTRO-GONIOMETER DIAGNOSTIC DEVICE
K901290 · LBB
Chattanooga Group, Inc.
Neurology · 195d
Cleared Oct 01, 1990
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · CBK
Ohmeda Medical
Anesthesiology · 146d
Cleared Oct 01, 1990
BAUER FLEXI-TEMNO BIOPSY NEEDLE
K902320 · FCG
Proact, Ltd.
Gastroenterology & Urology · 131d
Cleared Oct 01, 1990
RPI ENTERAL FEEDING BAG 1000ML AND 500ML
K902641 · KNT
Ridge Products, Inc.
Gastroenterology & Urology · 109d
Cleared Oct 01, 1990
DRIPTROL
K902808 · FLN
Trans-Pacific Healthcare-USA
General Hospital · 96d
Cleared Oct 01, 1990
SYNERMED CHOLESTEROL REAGENT KIT
K903015 · CHH
Synermed, Inc.
Chemistry · 83d
Cleared Oct 01, 1990
RACK-IT (R)
K903096 · FLE
Vengo Industries, Inc.
General Hospital · 80d
Cleared Oct 01, 1990
RESECTOSCOPE LOOPS
K903323 · KNS
Olympus Corp.
Gastroenterology & Urology · 68d
Cleared Oct 01, 1990
HICOR
K903375 · IZI
Siemens Gammasonics, Inc.
Radiology · 67d
Cleared Oct 01, 1990
CT-COMPATIBLE FLETCHER SYSTEM APPLICATOR
K903403 · IWJ
University of Michigan
Radiology · 62d