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
99985–100008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 1995
GIBSON ID A.E. TEST
K953247 · JTO
Gibson Laboratories, Inc.
Microbiology · 132d
Cleared Nov 20, 1995
FACS LOADER SYSTEM
K953302 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 129d
Cleared Nov 20, 1995
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714 · HRS
Zimmer, Inc.
Orthopedic · 103d
Cleared Nov 20, 1995
BIOCIRCUITS IOS T4 TEST CARTRIDGE
K953837 · KLI
Biocircuits Corp.
Chemistry · 97d
Cleared Nov 20, 1995
MED-TECH CLINICAL BLOOD GAS
K953935 · CHL
Medical Technical Gases Inc..
Chemistry · 94d
Cleared Nov 20, 1995
ABG POINT LOK NEEDLE PROTECTION DEVICE
K954015 · CBT
Devon Industries, Inc.
Anesthesiology · 87d
Cleared Nov 20, 1995
VARIANT HEMOGLOBINOPATHY PROGRAM
K954048 · GKA
Bio-Rad
Hematology · 84d
Cleared Nov 20, 1995
MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL
K954190 · MOS
Medical Advances, Inc.
Radiology · 75d
Cleared Nov 20, 1995
ARGON ACCESSORY WITH BLADE & NEEDLE ELECTRODE, ADAPTER BOX
K954229 · GEI
Valleylab, Inc.
General & Plastic Surgery · 70d
Cleared Nov 20, 1995
OPUS TDM CONTROLS
K954291 · DIF
Behring Diagnostics, Inc.
Toxicology · 67d
Cleared Nov 20, 1995
MAX-1000A/R1
K954590 · JAA
Toshiba America Medical Systems, In.C
Radiology · 49d
Cleared Nov 20, 1995
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
K954732 · JHI
Bio-Rad Laboratories, Inc.
Chemistry · 49d
Cleared Nov 17, 1995
ENTERPRISE
K935998 · DQX
Camp Intl., Inc.
Cardiovascular · 702d
Cleared Nov 17, 1995
OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM
K943305 · HET
Olympus America, Inc.
Obstetrics & Gynecology · 497d
Cleared Nov 17, 1995
DISCOVERY GRAPHIC PORTABLE SPIROMETER
K950223 · BZG
Futuremed America, Inc.
Anesthesiology · 311d
Cleared Nov 17, 1995
TS 564/PF
K950247 · FJK
Bressler, Amery & Ross
Gastroenterology & Urology · 301d
Cleared Nov 17, 1995
3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION...
K950739 · DWA
3M Health Care, Sarns
Cardiovascular · 273d
Cleared Nov 17, 1995
LIFESTYLE 55 (OCUFILCON D) HYDROPHILIC CONTACT LENS LIFESTYLE FREQUENCY 55...
K951893 · LPL
Permeable Technologies, Inc.
Ophthalmic · 207d
Cleared Nov 17, 1995
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K952224 · CAC
Stryker Instruments
Anesthesiology · 189d
Cleared Nov 17, 1995
RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN
K953458 · BZH
Raiinbow Step UP Systems, Inc.
Anesthesiology · 119d
Cleared Nov 17, 1995
PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT...
K953959 · HQC
Microsurgical Technology, Inc.
Ophthalmic · 87d
Cleared Nov 17, 1995
ANGIOVISION VIEWING STATION
K953972 · HKI
Medivision Medical Imaging, Ltd.
Ophthalmic · 86d
Cleared Nov 17, 1995
ANGIOVISION 1000
K953973 · HKI
Medivision Medical Imaging, Ltd.
Ophthalmic · 86d
Cleared Nov 17, 1995
FIELD TREND
K954037 · HPT
Synemed, Inc.
Ophthalmic · 81d