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
81217–81240 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2000
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
K002408 · LPL
Unilens Corp., USA
Ophthalmic · 71d
Cleared Oct 17, 2000
HITACHI ALTAIRE
K002420 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Oct 17, 2000
VISION 9000 PHASED ARRAY TORSO COIL
K002482 · MOS
Usa Instruments, Inc.
Radiology · 64d
Cleared Oct 17, 2000
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 36d
Cleared Oct 17, 2000
XPS NITRO SYSTEM
K002828 · ERL
Xomed, Inc.
Ear, Nose, Throat · 36d
Cleared Oct 17, 2000
CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST
K002898 · GEI
Curon Medical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 17, 2000
HEADBAND FOR BAHA
K002913 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 29d
Cleared Oct 17, 2000
MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
K002936 · LLZ
Sectra-Imtec AB
Radiology · 26d
Cleared Oct 17, 2000
SMALL STATURE USS
K994121 · MNI
Synthes (Usa)
Orthopedic · 316d
Cleared Oct 16, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K002870 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 33d
Cleared Oct 16, 2000
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200...
K002922 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 27d
Cleared Oct 16, 2000
MODIFICATION TO ISOBAR SPINAL SYSTEM
K002959 · KWP
Encore Orthopedics, Inc.
Orthopedic · 24d
Cleared Oct 13, 2000
TC-PLUS SOLUTION KNEE
K000666 · JWH
Plus Orthopedics
Orthopedic · 228d
Cleared Oct 13, 2000
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K001578 · DQO
AngioDynamics, Inc.
Cardiovascular · 144d
Cleared Oct 13, 2000
FOCUS
K002147 · MUJ
Computerized Medical Systems, Inc.
Radiology · 88d
Cleared Oct 13, 2000
ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE
K002168 · EJI
Ronvig Instruments, Ltd.
Dental · 88d
Cleared Oct 13, 2000
SIMPLICITY DISPOSABLE PEN NEEDLE
K002180 · FMI
Sterling Medivations, Inc.
General Hospital · 86d
Cleared Oct 13, 2000
BVI SLING
K002233 · PAJ
Bio-Vascular, Inc.
Obstetrics & Gynecology · 81d
Cleared Oct 13, 2000
ENDOCARE PERCUTANEOUS ACCESS SET
K002396 · KOD
Endocare, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 13, 2000
COALIZA PROTEIN S-FREE
K002467 · GGP
Instrumentation Laboratory CO
Hematology · 63d
Cleared Oct 13, 2000
PACIFIER THERMOMETER MODELS VT-901F, VT901C
K002562 · FLL
Valeo Corp.
General Hospital · 57d
Cleared Oct 13, 2000
C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
K002651 · DCK
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Oct 13, 2000
XIA SPINE SYSTEM
K002858 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Oct 13, 2000
MODIFICATION TO YASARGIL ANEURYSM CLIPS
K002871 · HCH
Aesculap, Inc.
Neurology · 29d