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
79081–79104 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2001
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
K010455 · KFF
Diagnostica-Stago
Hematology · 129d
Cleared Jun 07, 2001
SOLA 700,SOLA 500, SOLA 300
K010724 · FTD
Drager Medizintechnik GmbH
General & Plastic Surgery · 87d
Cleared Jun 07, 2001
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)
K010799 · FYA
Standard Textile Co., Inc.
General Hospital · 83d
Cleared Jun 07, 2001
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN...
K010862 · KGO
Allegiance Healthcare Corp.
General Hospital · 77d
Cleared Jun 07, 2001
HYCARE LATEX EXAMINATION GLOVE, POWDERED
K010875 · LYY
Hycare Intl. Co., Ltd.
General Hospital · 76d
Cleared Jun 07, 2001
UNI-LASER 470
K010885 · GEX
Medart Corp.
General & Plastic Surgery · 76d
Cleared Jun 07, 2001
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM
K011001 · LWM
Satelec
Dental · 90d
Cleared Jun 07, 2001
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
K011033 · JIH
Dade Behring, Inc.
Chemistry · 63d
Cleared Jun 07, 2001
PARADIGM QUICK-SET INFUSION SET
K011071 · FPA
Maersk Medical A/S
General Hospital · 59d
Cleared Jun 07, 2001
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE...
K011370 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER...
K011371 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 07, 2001
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT...
K011377 · LYY
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Jun 06, 2001
PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
K001917 · MJN
Arteria Medical Science, Inc.
Cardiovascular · 348d
Cleared Jun 06, 2001
FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
K002410 · IPF
Dysphagia, LLC
Physical Medicine · 303d
Cleared Jun 06, 2001
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
K002846 · BTM
Headstar Medical Products Co., Ltd.
Anesthesiology · 267d
Cleared Jun 06, 2001
CLARREN HELMET
K003035 · MVA
Children'S Hospital & Medical Center
Neurology · 251d
Cleared Jun 06, 2001
BACTEC MGIT 960 SIR KITS
K003062 · MJA
Bd Becton Dickinson Vacutainer...
Microbiology · 247d
Cleared Jun 06, 2001
OTRES TOOTHBRUSH SANITIZER MODEL TB100W
K003517 · MCF
Otres, LLC
Dental · 204d
Cleared Jun 06, 2001
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
K003570 · MCW
Bacchus Vascular, Inc.
Cardiovascular · 198d
Cleared Jun 06, 2001
SMITH & NEPHEW RESTIM
K003596 · IPF
Smith & Nephew, Inc.
Physical Medicine · 197d
Cleared Jun 06, 2001
CPR EZY MASK AND PAD
K003937 · LIX
Medteq Innovations Pty, Ltd.
Cardiovascular · 168d
Cleared Jun 06, 2001
STIMUPLEX HNS-11
K003983 · BXN
Stockert GmbH
Anesthesiology · 162d
Cleared Jun 06, 2001
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
K010083 · DTK
Cordis Corp.
Cardiovascular · 146d