Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82897–82920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2000
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3...
K993518 · FOZ
Medefil, Inc.
General Hospital · 238d
Cleared Jun 09, 2000
RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
K000336 · NBO
Rhigene, Inc.
Immunology · 127d
Cleared Jun 09, 2000
MULTI ADJUSTABLE FACE MASK
K000358 · DZB
Ortho Technology
Dental · 126d
Cleared Jun 09, 2000
MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
K000377 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 123d
Cleared Jun 09, 2000
MODEL APS ALTERNANS PROCESSING SYSTEM
K001034 · DPS
Cambridge Heart, Inc.
Cardiovascular · 70d
Cleared Jun 09, 2000
3M QUIK TEMP TEMPORIZATION MATERIAL
K001114 · EBG
3M Company
Dental · 64d
Cleared Jun 09, 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
K001178 · DJG
Microgenics Corp.
Toxicology · 59d
Cleared Jun 09, 2000
HI-RES 9000 PHASED ARRAY CAROTID COIL
K001210 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Jun 09, 2000
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML,...
K001287 · KPE
Sorenson Medical, Inc.
General Hospital · 46d
Cleared Jun 09, 2000
SYNERGY HEAD/NECK COIL
K001331 · MOS
Philips Medical Systems North...
Radiology · 43d
Cleared Jun 09, 2000
TERUMO U-100 INSULIN SYRING
K001474 · FMF
Terumo Medical Corp.
General Hospital · 29d
Cleared Jun 09, 2000
NARKOMED MRI , NM-MRI
K001488 · BSZ
Draeger Medical, Inc.
Anesthesiology · 28d
Cleared Jun 09, 2000
LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS...
K001557 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 21d
Cleared Jun 09, 2000
DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
K001574 · MID
Axis-Shield
Immunology · 18d
Cleared Jun 09, 2000
UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
K993316 · DXN
Ueda Avancer Corp.
Cardiovascular · 249d
Cleared Jun 09, 2000
MICRO-FRANCE TROCARS AND ACCESSORIES
K993653 · HET
Xomed, Inc.
Obstetrics & Gynecology · 224d
Cleared Jun 09, 2000
DELFIA NEONATAL IRT KIT
K993697 · CGZ
Wallac OY
Chemistry · 220d
Cleared Jun 09, 2000
PHARMASEED, MODEL BT-125-2
K993701 · KXK
Syncor International, Inc.
Radiology · 220d
Cleared Jun 09, 2000
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR...
K994199 · KKX
Custom Medical Products, Inc.
General Hospital · 179d
Cleared Jun 08, 2000
UNIVEC TWO PIECE SYRINGE
K000747 · FMF
Univec, Inc.
General Hospital · 93d
Cleared Jun 08, 2000
CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX,...
K000792 · KPO
Advanced Renal Technologies, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 08, 2000
TALON BALLOON DILATION CATHETER
K000798 · LIT
Boston Scientific Corp
Cardiovascular · 87d
Cleared Jun 08, 2000
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
K000813 · LZA
Allegiance Healthcare Coporation
General Hospital · 87d
Cleared Jun 08, 2000
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
K000815 · MHX
Datex-Ohmeda
Cardiovascular · 87d