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
95737–95760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1996
MITEK MICRO ANCHOR
K962511 · MBI
Mitek Products
Orthopedic · 132d
Cleared Nov 06, 1996
TRUZONE PEAK FLOW METER
K963089 · BZH
Monaghan Medical Corp.
Anesthesiology · 90d
Cleared Nov 06, 1996
P.F.C. CRUCIATE RETAING KNEE SYSTEM
K963117 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 86d
Cleared Nov 06, 1996
SPIDER STRAP
K963138 · FMQ
Bdm Medical, Inc.
General Hospital · 85d
Cleared Nov 06, 1996
FIRST AID KIT(S)
K963298 · BYG
Vector, Inc.
Anesthesiology · 77d
Cleared Nov 06, 1996
MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS
K963399 · FMQ
Morrison Medical Products
General Hospital · 69d
Cleared Nov 06, 1996
ANKLE RESTRAINT SYSTEM
K963416 · FMQ
Morrison Medical Products
General Hospital · 68d
Cleared Nov 06, 1996
POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL...
K963431 · FMQ
Zimmer, Inc.
General Hospital · 68d
Cleared Nov 06, 1996
THREADED FIXATION PIN
K963433 · JDW
Orthopaedic Biosystems, Ltd.
Orthopedic · 68d
Cleared Nov 06, 1996
ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST...
K963435 · FMQ
Zimmer Patient Care Division
General Hospital · 68d
Cleared Nov 06, 1996
MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP
K963494 · FMQ
Morrison Medical Products
General Hospital · 64d
Cleared Nov 06, 1996
MONOTUBE CARBON TUBE
K963614 · JEC
Howmedica Corp.
Orthopedic · 57d
Cleared Nov 06, 1996
NEO-CARE CATHETERIZATION TRAY
K963867 · FOZ
Klein-Baker Medical, Inc.
General Hospital · 41d
Cleared Nov 06, 1996
STERI-OSS SINUS AUGMENTATION KIT
K963897 · EMM
Steri-Oss, Inc.
Dental · 40d
Cleared Nov 06, 1996
TYCO BABY SESAME STREET SOFT TEETHER
K963912 · KKO
Regu-Tech Assoc., Inc.
Dental · 37d
Cleared Nov 06, 1996
HEMOCUE HEMOTROL
K964052 · GGM
Direct Solutions
Hematology · 37d
Cleared Nov 06, 1996
N/T PROTEIN CONTROL SL
K964065 · JJY
Behring Diagnostics, Inc.
Chemistry · 27d
Cleared Nov 05, 1996
OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS
K950853 · CBK
Drager, Inc.
Anesthesiology · 617d
Cleared Nov 05, 1996
TBM SPONGE
K960267 · LYC
Biocoll Laboratories, Inc.
Dental · 292d
Cleared Nov 05, 1996
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
K960287 · HQC
Nidek, Inc.
Ophthalmic · 288d
Cleared Nov 05, 1996
DERMAMEND GEL
K962089 · MGQ
Dermarx Corp.
General & Plastic Surgery · 160d
Cleared Nov 05, 1996
ANTHOS PHACTS VERSION MICROPLATE READER
K962113 · JJQ
Columbia Bioscience, Inc.
Chemistry · 158d
Cleared Nov 05, 1996
ACS CORTISOL IMMUNOASSAY
K962559 · JFT
Ciba Corning Diagnostics Corp.
Chemistry · 127d
Cleared Nov 05, 1996
FIXTURE MOUNT KIT
K963121 · DZE
Steri-Oss, Inc.
Dental · 85d