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
94129–94152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1997
TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
K955461 · BTO
VBM Medizintechnik GmbH
Anesthesiology · 476d
Cleared Mar 19, 1997
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
K960766 · DYF
Meadox Medicals, Div. Boston...
Cardiovascular · 387d
Cleared Mar 19, 1997
LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)
K960842 · LYY
Crocker Industrial Resources Sdn. Bhd.
General Hospital · 386d
Cleared Mar 19, 1997
SPINAL NEEDLES
K961151 · BSP
Hakko Shoji Co., Ltd.
Anesthesiology · 362d
Cleared Mar 19, 1997
TUOHY EPIDURAL NEEDLES
K961152 · BSP
Hakko Shoji Co., Ltd.
Anesthesiology · 362d
Cleared Mar 19, 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · DXT
B.Braun Medical, Inc.
Cardiovascular · 289d
Cleared Mar 19, 1997
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K963347 · BYE
Instrumentation Industries, Inc.
Anesthesiology · 205d
Cleared Mar 19, 1997
WALLACH INTEGRATION UNIT
K963348 · HGI
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 205d
Cleared Mar 19, 1997
EXTRA TENS (RI-2500) NEO TENS (RI-2000E)
K963507 · GZJ
Comtek Intl., Corp.
Neurology · 197d
Cleared Mar 19, 1997
PHILIPS SONO DIAGNOST 800
K963706 · IYO
Hewlett-Packard Co.
Radiology · 184d
Cleared Mar 19, 1997
IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
K963976 · DDG
Beckman Instruments, Inc.
Immunology · 166d
Cleared Mar 19, 1997
NARKOMED GS ANESTHESIA SYSTEM
K963994 · BSZ
Draeger Medical, Inc.
Anesthesiology · 166d
Cleared Mar 19, 1997
CRYOSIL SILICONE GEL SHEETING
K964047 · GEH
Biodermis Corp.
General & Plastic Surgery · 161d
Cleared Mar 19, 1997
CHASE TWO STAGE VENOUS RETURN CATHETER
K964195 · DWF
Chase Medical, Inc.
Cardiovascular · 149d
Cleared Mar 19, 1997
CAHSE AORTIC ROOT CANNULA
K964198 · DWF
Chase Medical, Inc.
Cardiovascular · 149d
Cleared Mar 19, 1997
CHASE CORONARY SINUS PERFUSION CANNULA
K964199 · DWF
Chase Medical, Inc.
Cardiovascular · 149d
Cleared Mar 19, 1997
STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL...
K964224 · GYC
Pmt Corp.
Neurology · 147d
Cleared Mar 19, 1997
HYDROPREP GEL
K964737 · GYB
D.O. Weaver Co.
Neurology · 114d
Cleared Mar 19, 1997
ENZYMUN-TEST PSA
K965085 · LTJ
Boehringer Mannheim Corp.
Immunology · 90d
Cleared Mar 19, 1997
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
K965093 · FAS
Omnitech Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 19, 1997
DAKOTA SMITH, NICOLE MILLER SUNGLASSES
K965125 · HQY
California Design Studio, Inc.
Ophthalmic · 86d
Cleared Mar 19, 1997
CUTTERSIL COMFORT
K965163 · ELW
Heraeus Kulzer, Inc.
Dental · 85d
Cleared Mar 19, 1997
CUTTERSIL COMFORT HARDENER
K965165 · ELW
Heraeus Kulzer, Inc.
Dental · 85d
Cleared Mar 19, 1997
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
K965190 · JWY
Accumed Intl., Inc.
Microbiology · 85d