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
25489–25512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2018
Sterile Disposable Syringes
K172694 · DXT
Shenyang Mastech Medical Device Co.,...
Cardiovascular · 302d
Cleared Jul 06, 2018
GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide,...
K173019 · PWJ
Ethicon, Inc.
Gastroenterology & Urology · 281d
Cleared Jul 06, 2018
Howell D.A.S.H Extraction Balloon with Multiple Sizing
K173659 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 219d
Cleared Jul 06, 2018
BIOLOX delta Option and Extra-long Heads
K173776 · LZO
Microport Orthopedics, Inc.
Orthopedic · 206d
Cleared Jul 06, 2018
Elecsys BRAHMS PCT
K173927 · PRI
Roche Diagnostics
Microbiology · 192d
Cleared Jul 06, 2018
Materialise PKA Guide System
K173970 · HSX
Materialise NV
Orthopedic · 189d
Cleared Jul 06, 2018
GammaTile
K180515 · KXK
Isoray Medical, Inc.
Radiology · 129d
Cleared Jul 06, 2018
Tyber Medical PT Interbody Spacer System
K180590 · ODP
Tyber Medical, LLC
Orthopedic · 122d
Cleared Jul 06, 2018
Vail ALIF Buttress Plate System
K180755 · KWQ
Evolution Spine, LLC
Orthopedic · 106d
Cleared Jul 06, 2018
Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja...
K180868 · FGE
Cook Ireland
Gastroenterology & Urology · 94d
Cleared Jul 06, 2018
CHROMID CARBA agar (CARB)
K181092 · JSO
Biomerieux S.A.
Microbiology · 72d
Cleared Jul 06, 2018
OLYMPIC Posterior Spinal Fixation System
K181139 · NKB
Astura Medical, LLC
Orthopedic · 67d
Cleared Jul 06, 2018
InPen Dose Calculator
K181327 · NDC
Companion Medical, Inc.
General Hospital · 49d
Cleared Jul 06, 2018
ASTRA-OCT Spine System
K181350 · NKG
Spinecraft, LLC
Orthopedic · 45d
Cleared Jul 06, 2018
DRI Cocaine Metabolite Assay
K181499 · DIO
Microgenics Corporation
Toxicology · 29d
Cleared Jul 06, 2018
Endorate Valve Sets
K181509 · OCX
Smartdata Suzhou Co., Ltd.
Gastroenterology & Urology · 28d
Cleared Jul 05, 2018
Nitrile Patient Examination Powder Free Glove, Textured, Black
K161085 · LZA
Multisafe Sdn. Bhd.
General Hospital · 808d
Cleared Jul 05, 2018
CheckMyHeart Plus
K172778 · DPS
Dailycare Biomedical, Inc.
Cardiovascular · 294d
Cleared Jul 05, 2018
ASAHI PTCA Guide Wire ASAHI SION black
K173277 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 265d
Cleared Jul 05, 2018
Fractional CO2 Surgical Laser System
K173359 · GEX
Ami, Inc.
General & Plastic Surgery · 252d
Cleared Jul 05, 2018
SureForm 60 and SureForm 60 Reloads
K173721 · NAY
Intuitive Surgical
General & Plastic Surgery · 212d
Cleared Jul 05, 2018
Disposable Hot Biopsy Forceps
K180018 · KGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 184d
Cleared CT Jul 05, 2018
400um Perforator and Accessory Vein Ablation Kit
K181044 · GEX
AngioDynamics, Inc.
General & Plastic Surgery · 77d
Cleared Jul 05, 2018
12F Tri-Flow Triple Lumen Catheter
K181175 · NIE
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 64d