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
127321–127344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1990
BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE
K897005 · JOH
Helix Medical, Inc.
Anesthesiology · 88d
Cleared Mar 16, 1990
PICSO CANNULA, CATALOG CODE 94315
K897022 · DWF
Dlp, Inc.
Cardiovascular · 87d
Cleared Mar 16, 1990
OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID
K897023 · LRB
Audina Hearing Instrument
Ear, Nose, Throat · 87d
Cleared Mar 16, 1990
SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
K897039 · DTR
3M Company
Cardiovascular · 88d
Cleared Mar 16, 1990
HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS
K897041 · DYB
C.R. Bard, Inc.
Cardiovascular · 88d
Cleared Mar 16, 1990
GIBSON ENDOLYMPHATIC SHUNT
K897049 · ESZ
Hood Laboratories
Ear, Nose, Throat · 88d
Cleared Mar 16, 1990
MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH
K897051 · DQO
Cathlab Corp.
Cardiovascular · 88d
Cleared Mar 16, 1990
THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM
K897057 · BYH
Thayer Medical Corp.
Anesthesiology · 88d
Cleared Mar 16, 1990
CENTURION VAGINAL SPECULUM
K897100 · HIC
Tri-State Hospital Supply Corp.
Obstetrics & Gynecology · 85d
Cleared Mar 16, 1990
SYSTEM TEN MODEL 100 SURGICAL SYSTEM
K900003 · JDX
Advanced Osseous Technologies
Orthopedic · 73d
Cleared Mar 16, 1990
H.E.A.R.T. NEBULIZER
K900228 · CAF
B&B Medical Technologies, Inc.
Anesthesiology · 58d
Cleared Mar 16, 1990
NASAL E.T. TAPE
K900787 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 24d
Cleared Mar 16, 1990
GAS SAMPLING NASAL CANNULA
K900979 · CCK
Gibeck, Inc.
Anesthesiology · 14d
Cleared Mar 16, 1990
COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEM
K901069 · KHX
Computerized Functional Testing Corp.
Physical Medicine · 9d
Cleared Mar 15, 1990
CUSTOM TRAYS, KITS
K894610 · FSM
L H M Ent., Inc.
General & Plastic Surgery · 238d
Cleared Mar 15, 1990
PLATELIA TOXO IGM KIT
K894948 · LGD
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 224d
Cleared Mar 15, 1990
CHEMO-TOUCH
K895195 · LZC
Medical Resources, Ltd.
General Hospital · 216d
Cleared Mar 15, 1990
WIDEX HEARING AID MODELS ES9T AND ES9H
K895981 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 154d
Cleared Mar 15, 1990
WIDEX HEARING AID MODEL ES 10 ASP T
K895982 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 154d
Cleared Mar 15, 1990
PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359
K896174 · GGP
Helena Laboratories
Hematology · 141d
Cleared Mar 15, 1990
MODEL 404A I.V. INFUSION PUMP ANALYZER
K897096 · FRN
Dynatech/Nevada, Inc.
General Hospital · 84d
Cleared Mar 15, 1990
THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT
K897144 · KLI
Medix Biotech, Inc.
Chemistry · 78d
Cleared Mar 15, 1990
OLYMPUS DIRECT BILIRUBIN
K897175 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Mar 15, 1990
NON-ELECTRIC BIOPSY FORCEPS
K900015 · FCL
Esco Precision, Inc.
Gastroenterology & Urology · 72d