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
83761–83784 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2000
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI...
K993417 · HCG
Boston Scientific, Target
Neurology · 112d
Cleared Jan 21, 2000
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
K993418 · HCG
Boston Scientific, Target
Neurology · 112d
Cleared Jan 21, 2000
ABI VEST AIRWAY CLEARANCE SYSTEM
K993629 · BYI
American Biosystems, Inc.
Anesthesiology · 86d
Cleared Jan 21, 2000
CITATION TMZF HA STEM
K993768 · MEH
Howmedica Osteonics Corp.
Orthopedic · 74d
Cleared Jan 21, 2000
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER...
K994331 · MXC
Medtronic Vascular
Cardiovascular · 29d
Cleared Jan 20, 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067 · CJE
Teco Diagnostics
Chemistry · 10d
Cleared Jan 20, 2000
GOWN BACK, MODEL 13-403N
K992436 · FYA
Techstyles
General Hospital · 182d
Cleared Jan 20, 2000
IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
K992634 · LAF
Diagnostic Products Corp.
Toxicology · 167d
Cleared Jan 20, 2000
PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
K992675 · LZA
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 163d
Cleared Jan 20, 2000
ACON ONE STEP HOME PREGNANCY TEST STRIP
K993483 · LCX
ACON Laboratories, Inc.
Chemistry · 98d
Cleared Jan 20, 2000
MODIFICATION TO LASER-SHIELD II
K993582 · BTR
Xomed, Inc.
Anesthesiology · 90d
Cleared Jan 20, 2000
HP M2376A DEVICE LINK SYSTEM
K993587 · MQS
Hewlett-Packard Co.
Gastroenterology & Urology · 90d
Cleared Jan 20, 2000
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
K993598 · LMA
Vidar Systems Corp.
Radiology · 87d
Cleared Jan 20, 2000
MRI EQUIPMENT COVER
K993682 · LNH
Image-Guided Neurologics, Inc.
Radiology · 80d
Cleared Jan 20, 2000
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
K993736 · LPH
Exactech, Inc.
Orthopedic · 77d
Cleared Jan 20, 2000
EC-7701 FLUID WARMING CABINET
K993797 · LDQ
Enthermics Medical Systems, Inc.
General & Plastic Surgery · 72d
Cleared Jan 20, 2000
MSAS PROFESSIONAL
K993824 · GZO
Biomeridian, Int.
Neurology · 69d
Cleared Jan 20, 2000
UFI GEL HARD
K993827 · EBI
Voco GmbH
Dental · 69d
Cleared Jan 20, 2000
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
K993864 · LYY
Supermax Sdn Bhd
General Hospital · 66d
Cleared Jan 20, 2000
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
K993865 · LYY
Supermax Sdn Bhd
General Hospital · 66d
Cleared Jan 20, 2000
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · DJR
Syva Co.
Chemistry · 57d
Cleared Jan 20, 2000
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100...
K994013 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 55d
Cleared Jan 20, 2000
CAUTERY GRASPER/DISSECTOR
K994019 · HQP
Starion Instruments
Ophthalmic · 55d
Cleared Jan 20, 2000
MTP DISPOSABLE TROCARS
K994066 · GCJ
Mtp Medical Technical Promotion GmbH
General & Plastic Surgery · 50d