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
101065–101088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1995
WAKO AUTOKIT APO A1
K952615 · JHN
Wako Chemicals USA, Inc.
Immunology · 94d
Cleared Sep 08, 1995
NEXFLEX TOTAL HIP SYSTEM
K952629 · JDI
Nexmed, Inc.
Orthopedic · 92d
Cleared Sep 08, 1995
DISPOSABLE BIOPSY FORCEP
K952630 · HRX
Neuro Navigational Corp.
Orthopedic · 92d
Cleared Sep 08, 1995
DISPOSABLE TOOTHED GRASPING FORCEP
K952639 · HRX
Neuro Navigational Corp.
Orthopedic · 91d
Cleared Sep 08, 1995
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · JEC
Howmedica Corp.
Orthopedic · 85d
Cleared Sep 08, 1995
DOSI-FLOW, MODELS 20 & 30
K952810 · FPA
Leventon, S.A.
General Hospital · 81d
Cleared Sep 08, 1995
PC-LOCK
K952855 · DYH
Midwest Orthodontic Mfg.
Dental · 78d
Cleared Sep 08, 1995
MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
K952873 · GTZ
Medix Biotech, Inc.
Microbiology · 94d
Cleared Sep 08, 1995
DENTRAY II PLUS TRAY ADHESIVE
K952930 · ELW
Confi-Dental Products Co.
Dental · 81d
Cleared Sep 08, 1995
LOW PROFILE TITANIUM MODEL CATALOG #1003
K953017 · LJT
Therex Corp.
General Hospital · 71d
Cleared Sep 08, 1995
UNI-SITE
K953018 · MGP
Ttl Medical
General & Plastic Surgery · 71d
Cleared Sep 08, 1995
SLT 28MM XXL FEMORAL HEAD
K953025 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 71d
Cleared Sep 08, 1995
WOUNDFOAM 4 X 4
K953070 · KMF
Trinity Laboratories, Inc.
General & Plastic Surgery · 70d
Cleared Sep 08, 1995
QUIK-STITCH
K953123 · GCJ
Coral Medical, Inc.
General & Plastic Surgery · 65d
Cleared Sep 08, 1995
EXUSORB STERILE ABSORBENT
K953131 · KMF
O.R. Resources, Inc.
General & Plastic Surgery · 64d
Cleared Sep 08, 1995
ULTRACID DISINFECTING SOLOUTION
K953167 · LBH
Ultradent Products, Inc.
Dental · 63d
Cleared Sep 08, 1995
ULTRACID F DISINFECTING SOLUTION
K953168 · LBH
Ultradent Products, Inc.
Dental · 63d
Cleared Sep 08, 1995
COMBINATION KIT
K953331 · DZE
Steri-Oss, Inc.
Dental · 53d
Cleared Sep 08, 1995
TMR48
K953342 · INO
Pride Health Care, Inc.
Physical Medicine · 59d
Cleared Sep 08, 1995
UROVISION JANUS
K953353 · FEN
Life-Tech Intl., Inc.
Gastroenterology & Urology · 53d
Cleared Sep 08, 1995
STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW
K953369 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 52d
Cleared Sep 08, 1995
NG SECURE
K953375 · KNT
M.C. Johnson Co., Inc.
Gastroenterology & Urology · 52d
Cleared Sep 08, 1995
ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES
K953496 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 44d
Cleared Sep 08, 1995
OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL
K953498 · GKZ
Immunotech, Inc.
Hematology · 44d