Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
72553–72576 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2003
SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH
K030684 · OCU
Acmi Corporation
Gastroenterology & Urology · 90d
Cleared Jun 03, 2003
ULTRABLATOR ELECTRODE
K030720 · GEI
Linvatec Corp.
General & Plastic Surgery · 88d
Cleared Jun 03, 2003
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
K030724 · LZO
Zimmer, Inc.
Orthopedic · 88d
Cleared Jun 03, 2003
7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS
K030822 · BZD
Hans Rudolph, Inc.
Anesthesiology · 81d
Cleared Jun 03, 2003
NANMA VACUUM PUMP
K030913 · LKY
Nanma Mfg Co., Ltd.
Gastroenterology & Urology · 71d
Cleared Jun 03, 2003
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0
K031000 · DQK
C.R. Bard, Inc.
Cardiovascular · 64d
Cleared Jun 02, 2003
STRYKER NAVIGATION SYSTEM-KNEE MODULE
K022579 · HAW
Stryker Leibinger
Neurology · 301d
Cleared Jun 02, 2003
CRP-LATEX (II)X2 SEIKEN ASSAY KIT
K030545 · DCK
Denka Seiken Co., Ltd.
Immunology · 102d
Cleared Jun 02, 2003
CRP (II) CALIBRATORS
K030546 · JIS
Denka Seiken Co., Ltd.
Immunology · 102d
Cleared Jun 02, 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K030848 · HWC
Karl Storz Endoscopy
Orthopedic · 77d
Cleared Jun 02, 2003
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135 · CFR
Dade Behring, Inc.
Chemistry · 54d
Cleared Jun 02, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE
K031306 · LON
Becton, Dickinson & CO
Microbiology · 39d
Cleared Jun 02, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY
K031506 · LGD
Beckman Coulter, Inc.
Microbiology · 19d
Cleared May 30, 2003
VAPOTHERM 2000H
K013486 · BTT
Vapotherm, Inc.
Anesthesiology · 588d
Cleared May 30, 2003
SPECTRUM SILICONE CATHETER
K021557 · FOZ
Cook, Inc.
General Hospital · 382d
Cleared May 30, 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K023887 · HWC
Inion , Ltd.
Orthopedic · 190d
Cleared May 30, 2003
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
K030587 · DRN
S-Tct Health, Inc.
Cardiovascular · 94d
Cleared May 30, 2003
FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON...
K030593 · LPL
X-Cel Contacts, A Walman Co.
Ophthalmic · 94d
Cleared May 30, 2003
STRYKER PAINPUMP2
K030661 · MEA
Stryker Instruments
General Hospital · 88d
Cleared May 30, 2003
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K030726 · DTN
Gish Biomedical, Inc.
Cardiovascular · 84d
Cleared May 30, 2003
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES...
K030813 · EZL
Primary Care Solutions, Inc.
Gastroenterology & Urology · 77d
Cleared May 30, 2003
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
K030839 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 74d
Cleared May 30, 2003
REBILDA DC
K030914 · EBF
Voco GmbH
Dental · 67d
Cleared May 30, 2003
GRANDIO
K030915 · EBF
Voco GmbH
Dental · 67d