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
71089–71112 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K032409 · MQV
Orthovita, Inc.
Orthopedic · 25d
Cleared Aug 29, 2003
BINDER CO2 INCUBATOR SERIE CB
K032526 · MQG
Binder GmbH
Obstetrics & Gynecology · 14d
Cleared Aug 29, 2003
S2 NAIL SYSTEM
K032579 · HSB
Howmedica Osteonics Corp.
Orthopedic · 8d
Cleared Aug 28, 2003
INION OTPS BIODEGRADABLE PIN
K031712 · HTY
Inion , Ltd.
Orthopedic · 87d
Cleared Aug 28, 2003
NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR...
K032293 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Aug 28, 2003
NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT...
K032294 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Aug 28, 2003
JOBST TRAVEL SOCKS
K032325 · DWL
Bsn-Jobst, Inc.
General Hospital · 31d
Cleared Aug 28, 2003
BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
K032432 · FMJ
Busse Hospital Disposables, Inc.
General Hospital · 22d
Cleared Aug 28, 2003
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
K032453 · JJY
Bionostics, Inc.
Chemistry · 17d
Cleared Aug 27, 2003
TSO3 OZONE CHEMICAL INDICATOR
K021161 · JOJ
Technologies of Sterilization With...
General Hospital · 503d
Cleared Aug 27, 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · DJR
Microgenics Corp.
Toxicology · 302d
Cleared Aug 27, 2003
PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
K030381 · BTO
Portex , Ltd.
Anesthesiology · 203d
Cleared Aug 27, 2003
CUSTOM PRODUCTS IVF WORKSTATION TYPE WKST-24*36, WKST-24*48, WKST-24*60,...
K030525 · MQG
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 189d
Cleared Aug 27, 2003
MICROPEAK
K030586 · BZH
Micro Direct, Inc.
Anesthesiology · 184d
Cleared Aug 27, 2003
KENTEX DISPOSABLE VAGINAL SPECULUM
K030693 · HIB
Kentron Health Care, Inc.
Obstetrics & Gynecology · 175d
Cleared Aug 27, 2003
MOBILE BATTERY SERVICE STATION (MBSS)
K030898 · MKJ
Ad Elektronik GmbH
Cardiovascular · 159d
Cleared Aug 27, 2003
D-10 HEMOGLOBIN A1C
K031043 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 148d
Cleared Aug 27, 2003
HEARTSTART MRX, MODEL M3535A
K031187 · MKJ
Philips Medical Systems
Cardiovascular · 134d
Cleared Aug 27, 2003
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS
K031665 · HQF
Iridex Corp
Ophthalmic · 90d
Cleared Aug 27, 2003
VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES
K031748 · EZL
Vitalcare Group, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 27, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML
K031984 · LON
Becton, Dickinson & CO
Microbiology · 62d
Cleared Aug 27, 2003
LCD MONITOR, RADIFORCE G11, G31, G51
K032026 · LLZ
Eizo Nanao Corporation
Radiology · 58d
Cleared Aug 27, 2003
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
K032041 · DWF
LeMaitre Vascular, Inc.
Cardiovascular · 57d
Cleared Aug 27, 2003
WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
K032069 · DQY
AngioDynamics, Inc.
Cardiovascular · 55d