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
97129–97152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1996
STS SHIELD WITH MASK
K961402 · FXX
Innovative Outsourcing Solutions
General Hospital · 92d
Cleared Jul 12, 1996
DEPUY ENDURANCE CALCAR HIP PROSTHESIS
K961619 · JDI
Depuy, Inc.
Orthopedic · 77d
Cleared Jul 12, 1996
FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO...
K962355 · CDP
Bayer Corp.
Chemistry · 24d
Cleared Jul 12, 1996
BOSTON CONTACT LENS CASE
K962512 · LRX
Polymer Technology Div. Wilmington...
Ophthalmic · 15d
Cleared Jul 11, 1996
RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
K954163 · DXH
Cardiac Evaluation Center, Inc.
Cardiovascular · 310d
Cleared Jul 11, 1996
QUICKELS QS 200 SYSTEM
K954772 · DRX
Ferguson Medical
Cardiovascular · 272d
Cleared Jul 11, 1996
QUICKELS QS 100 SYSTEM
K954773 · DRX
Ferguson Medical
Cardiovascular · 272d
Cleared Jul 11, 1996
OMNI-TRAK PATIENT MONITORING SYSTEM
K955045 · DPS
Invivo Research, Inc.
Cardiovascular · 251d
Cleared Jul 11, 1996
TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
K955755 · MHJ
Trend Scientific, Inc.
Microbiology · 204d
Cleared Jul 11, 1996
SYSTEM 6500 ABC ELECTROSURGICAL UNIT
K955834 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 198d
Cleared Jul 11, 1996
OSTEOMARK
K961562 · JMM
Ostex Intl., Inc.
Chemistry · 80d
Cleared Jul 11, 1996
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
K961726 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 69d
Cleared Jul 11, 1996
CARASYN HYDROGEL WOUND PRODUCTS
K961758 · MGQ
Carrington Laboratories, Inc.
General & Plastic Surgery · 69d
Cleared Jul 11, 1996
ADVANCED MICRO-OSMOMETER MODEL 3300
K962056 · JJM
Advanced Instruments, Inc.
Chemistry · 44d
Cleared Jul 11, 1996
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
K962373 · DCK
Behring Diagnostics, Inc.
Immunology · 21d
Cleared Jul 11, 1996
SORBCEL ALGINATE/CMC WOUND DRESSING
K962421 · KMF
Innovative Technologies , Ltd.
General & Plastic Surgery · 17d
Cleared Jul 10, 1996
BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
K954065 · JHI
Biochem Immunosystems (U.S.), Inc.
Chemistry · 315d
Cleared Jul 10, 1996
WALLSTENT ENTERAL ENDOPROTHESIS
K954290 · MQR
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 300d
Cleared Jul 10, 1996
NEOSONO 2000
K955088 · LQY
American Medical & Dental Corp.
Dental · 246d
Cleared Jul 10, 1996
COPALIS CMV TOTAL ANTIBODY ASSAY
K955799 · LJO
Sienna Biotech, Inc.
Microbiology · 201d
Cleared Jul 10, 1996
I.V. ADMINISTRATION SETS
K955821 · FPA
Medical Associates Network, Inc.
General Hospital · 197d
Cleared Jul 10, 1996
ACUPUNCTURE NEEDLE PACK
K960769 · MQX
Acu Med, Inc.
General Hospital · 135d
Cleared Jul 10, 1996
SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE
K961133 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 111d
Cleared Jul 10, 1996
OCUSYSTEM ART ADVANTAGE
K961243 · HQC
Surgical Design Corp.
Ophthalmic · 100d