FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71425–71448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303 · JXG
Aesculap, Inc.
Neurology · 41d
Cleared Jun 04, 2003
CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER
K031488 · GEX
Cynosure, Inc.
General & Plastic Surgery · 23d
Cleared Jun 03, 2003
SHANCHUAN SYRINGE
K021993 · FMF
Shangdong Zibo Shanchuan Medical...
General Hospital · 350d
Cleared Jun 03, 2003
MAGLIFE C/MAGLIFE C PLUS
K023195 · MWI
Schiller Medical S.A.
Cardiovascular · 251d
Cleared Jun 03, 2003
ARTERIALFLOW SYSTEM, MODEL 32A
K024019 · JOW
Aircast, Inc.
Cardiovascular · 180d
Cleared Jun 03, 2003
PNEUTON VENTILATOR
K024344 · CBK
Airon Corporation
Anesthesiology · 158d
Cleared Jun 03, 2003
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 95d
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