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
126193–126216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 19, 1990
TAMCENAN OCULAR EXPLANTS AND BANDS
K902308 · HQX
Tamcenan Corp.
Ophthalmic · 28d
Cleared Jun 19, 1990
RX ROCKER WHEELCHAIR
K902438 · IOR
The RX Rocker Corp.
Physical Medicine · 18d
Cleared Jun 19, 1990
RX ROCKER TRIUMPH WHEELCHAIR
K902439 · IOR
The RX Rocker Corp.
Physical Medicine · 18d
Cleared Jun 18, 1990
MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT
K894241 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 362d
Cleared Jun 18, 1990
CONCENTRIC ELECTRODE TYPE #13R01, 13R02
K895460 · IKT
Dantec Electronics, Inc.
Neurology · 285d
Cleared Jun 18, 1990
PHARMASEAL EPIDURAL CATHETER
K896712 · BSO
Baxter Healthcare Corp
Anesthesiology · 202d
Cleared Jun 18, 1990
DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/12
K896874 · IKT
Dantec Medical, Inc.
Neurology · 192d
Cleared Jun 18, 1990
PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL
K897194 · BSO
Baxter Healthcare Corp
Anesthesiology · 171d
Cleared Jun 18, 1990
DESERET OPTIMA INTRAVASCULAR CATHETER
K900116 · FOZ
Deseret Medical, Inc.
General Hospital · 160d
Cleared Jun 18, 1990
INVACARE EXTENDED CARE NURSING HOME BED
K900151 · FNL
Invacare Corp.
General Hospital · 158d
Cleared Jun 18, 1990
J&S HDL CHOLESTEROL PRECIPITATING REAGENT
K900218 · LBL
J.S. Medical Assoc.
Chemistry · 152d
Cleared Jun 18, 1990
MAX TRANSPORT VENTILATOR
K900465 · CBK
Hamilton Medical, Inc.
Anesthesiology · 138d
Cleared Jun 18, 1990
IONOMETER EH-HK AND ACCESSORIES
K901041 · CEM
Fresenius USA, Inc.
Chemistry · 104d
Cleared Jun 18, 1990
AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES
K901138 · CAC
Boehringer Laboratories
Anesthesiology · 98d
Cleared Jun 18, 1990
DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE
K901428 · FDI
Telemed Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
TELEMED ERCP CANNULA
K901431 · FGE
Telemed Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
BRONCHIAL CYTOLOGY BRUSH
K901436 · FDX
Telemed Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE
K901437 · FBK
Telemed Systems, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 18, 1990
ZIMMON PAPILLOTOME
K901443 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jun 18, 1990
CUDA SURGICAL LIGHT
K901491 · FST
Cuda Products Co.
General & Plastic Surgery · 81d
Cleared Jun 18, 1990
SAF-T CLIK I.V. IN-LINE CONNECTOR & EXTENSION SET
K901729 · FPA
Ryan Medical, Inc.
General Hospital · 63d
Cleared Jun 18, 1990
LUMISCOPE ELECTRODES MODELS EL-08,11,15,06,21,25
K901809 · GXY
Lumiscope Co., Inc.
Neurology · 59d
Cleared Jun 18, 1990
WAKO(TM) MICRO-ALBUMIN
K902216 · JIQ
Wako Chemicals USA, Inc.
Chemistry · 33d
Cleared Jun 18, 1990
AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT
K902259 · JWX
Orthomet, Inc.
Microbiology · 28d