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
100345–100368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 02, 1996
BALLOON UTERINE STENT
K952527 · KNA
Cook Urological, Inc.
Obstetrics & Gynecology · 215d
Cleared Jan 02, 1996
PACIFIER THERMOMETER
K952541 · FLL
Regitar U.S.A., Inc.
General Hospital · 249d
Cleared Jan 02, 1996
MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE
K954020 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 158d
Cleared Jan 02, 1996
OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE
K954631 · LYC
Ceramed Corp.
Dental · 88d
Cleared Jan 02, 1996
ASPECT ACQUISITION MODULE (AAM)
K954875 · LMA
Aspect Electronics, Inc.
Radiology · 70d
Cleared Jan 02, 1996
BELLEGLASHP
K955331 · EBG
Sybron Dental Specialties, Inc.
Dental · 43d
Cleared Jan 02, 1996
LITEX 680
K955759 · EBZ
Dentamerica
Dental · 15d
Cleared Dec 29, 1995
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000...
K950856 · DRO
Zoll Medical Corp
Cardiovascular · 305d
Cleared Dec 29, 1995
LIFEPAK 11
K951593 · DRO
Physio-Control Corp.
Cardiovascular · 267d
Cleared Dec 29, 1995
PYRILINKS-D ASSAY KIT
K952320 · JMM
Metra Biosystems, Inc.
Chemistry · 225d
Cleared Dec 29, 1995
MITEK GII ANCHOR
K953877 · MBI
Mitek Surgical Products, Inc.
Orthopedic · 165d
Cleared Dec 29, 1995
AXSYM DIGITOXIN
K954420 · LFM
Abbott Laboratories
Toxicology · 99d
Cleared Dec 29, 1995
SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE
K954438 · CCW
Rms Div.
Anesthesiology · 95d
Cleared Dec 29, 1995
AUGUSTINE INTUBATION GUIDE
K954446 · CCW
Augustine Medical, Inc.
Anesthesiology · 95d
Cleared Dec 29, 1995
CONDENSATE COLLECTION KIT
K954480 · CAI
Nova-Ventrx
Anesthesiology · 94d
Cleared Dec 29, 1995
AUTOMATED TRU-CUT BIOPSY DEVICE
K954529 · KNW
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Dec 29, 1995
BTE CPM-10
K955105 · BXB
Baltimore Therapeutic Equipment Co.
Physical Medicine · 51d
Cleared Dec 29, 1995
BTE CPM-20
K955106 · BXB
Baltimore Therapeutic Equipment Co.
Physical Medicine · 51d
Cleared Dec 29, 1995
DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A
K955142 · FLL
Salutron, Inc.
General Hospital · 46d
Cleared Dec 29, 1995
INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY
K955390 · CFL
Corning Nichols Diagnostics
Chemistry · 35d
Cleared Dec 29, 1995
CONVEEN URINE BAG - STERILE
K955609 · FAQ
Coloplast Corp.
Gastroenterology & Urology · 21d
Cleared Dec 28, 1995
FUTREX-5000
K922600 · DSB
Futrex, Inc.
Cardiovascular · 1304d
Cleared Dec 28, 1995
FUTREX-5000A
K922601 · DSB
Futrex, Inc.
Cardiovascular · 1304d
Cleared Dec 28, 1995
A&D UN-231 ULTRASONIC HANDY NEBULIZER
K941627 · CAF
A & D Corporate
Anesthesiology · 633d