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
96265–96288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1996
QUANTEX IGM
K962201 · DFT
Instrumentation Laboratory CO
Immunology · 110d
Cleared Sep 25, 1996
EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM
K962552 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 86d
Cleared Sep 25, 1996
SUPRACONDYLAR INTRAMEDULLARY NAIL
K962561 · HSB
Zimmer, Inc.
Orthopedic · 86d
Cleared Sep 25, 1996
J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS,...
K962757 · MNH
J.B.S., S.A.
Orthopedic · 71d
Cleared Sep 25, 1996
TARGIS SYSTEM
K962878 · EBF
Ivoclar North America, Inc.
Dental · 63d
Cleared Sep 25, 1996
IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS
K962927 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 58d
Cleared Sep 25, 1996
S-53 INTRORAL DENTAL SYSTEM
K962979 · DZA
Del Medical Systems Corp.
Dental · 56d
Cleared Sep 24, 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045 · LFX
Abbott Laboratories
Microbiology · 392d
Cleared Sep 24, 1996
AMD HOME HEALTH MONITORING SYSTEM
K960337 · CGA
Advanced Medical Devices, Inc.
Chemistry · 244d
Cleared Sep 24, 1996
HEMOCUE B-HEMOGLOBIN SYSTEM
K961312 · GKR
Hemocue, Inc.
Hematology · 173d
Cleared Sep 24, 1996
QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
K961544 · DGR
Consolidated Technologies, Inc.
Immunology · 155d
Cleared Sep 24, 1996
QUALITROL RF CONTROLS
K961545 · DHR
Consolidated Technologies, Inc.
Immunology · 155d
Cleared Sep 24, 1996
QUALITROL MONO CONTROL SERUM SET
K961550 · KTN
Consolidated Technologies, Inc.
Immunology · 155d
Cleared Sep 24, 1996
AIR MOTOR HANDPIECE TN-102
K962542 · EFB
Nsk Nakanishi, Inc.
Dental · 88d
Cleared Sep 24, 1996
INSUFFLATION NEEDLE
K963359 · HET
Applied Medical Resources
Obstetrics & Gynecology · 29d
Cleared Sep 23, 1996
ARTERIAL VENOUS BLOOD TUBING SET
K953823 · FJK
Medisystems Corp.
Gastroenterology & Urology · 405d
Cleared Sep 23, 1996
PROD NO. 01-1694 - 4X4 FOAM DRESSING
K954728 · KMF
Continental Medical Laboratories, Inc.
General & Plastic Surgery · 346d
Cleared Sep 23, 1996
MAMMARY SIZER
K961356 · MRD
General Surgical Innovations
General & Plastic Surgery · 168d
Cleared Sep 23, 1996
KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
K961522 · HTY
Synvasive Technology, Inc.
Orthopedic · 154d
Cleared Sep 23, 1996
DIGIPAN
K961826 · EHD
Trophy Radiologie
Radiology · 133d
Cleared Sep 23, 1996
AUTO SUTURE MODIFIED VCS CLIP APPLIER
K962043 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 118d
Cleared Sep 23, 1996
MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR
K962462 · IPF
Smith and Nephew Donjoy, Inc.
Physical Medicine · 90d
Cleared Sep 23, 1996
OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS
K962592 · GEX
Alcon Laboratories
General & Plastic Surgery · 83d
Cleared Sep 23, 1996
PRIME MODULAR ENDO HEAD
K962646 · KWL
Orthopaedic Innovations, Inc.
Orthopedic · 77d