FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71929–71952 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2003
PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US
K031470 · BZD
Tyco Healthcare Nancy
Anesthesiology · 27d
Cleared Jun 05, 2003
MODIFICATION TO CAVERMAP SURGICAL AID
K031527 · FGM
Blue Torch Medical Technologies
Gastroenterology & Urology · 21d
Cleared Jun 04, 2003
BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC
K023691 · NFA
Boston Scientific Epi
Cardiovascular · 215d
Cleared Jun 04, 2003
SHELHIGH BIORING
K023940 · KRH
Shelhigh, Inc.
Cardiovascular · 190d
Cleared Jun 04, 2003
PALOMAR LIGHTCUBE
K024179 · ILY
Palomar Medical Products, Inc.
Physical Medicine · 168d
Cleared Jun 04, 2003
CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT
K030700 · GEX
Biolitec, Inc.
General & Plastic Surgery · 90d
Cleared Jun 04, 2003
BIO-MODULAR SHOULDER SYSTEM
K030710 · KWT
Biomet, Inc.
Orthopedic · 90d
Cleared Jun 04, 2003
LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112
K030824 · GCJ
Hakko Medical Co., Ltd.
General & Plastic Surgery · 82d
Cleared Jun 04, 2003
3-CCD DIGITAL CAMERA SYSTEM
K031098 · GCJ
Linvatec Corp.
General & Plastic Surgery · 58d
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