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
95353–95376 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1996
PALLADIA 76
K964572 · EJT
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
PIEDMONT 70 (CH-35)
K964573 · EJT
Gateway Alloys, Inc.
Dental · 22d
Cleared Dec 06, 1996
ARTICULAR HEARING AIDS
K964603 · ESD
Decibel Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared Dec 05, 1996
VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM
K935778 · CCE
Via Medical Corp.
Anesthesiology · 1098d
Cleared Dec 05, 1996
HYPERBARIC CHAMBER
K960389 · CBF
Tampa Hyperbaric Ent.
Anesthesiology · 318d
Cleared Dec 05, 1996
GISH RELIANCE OXYGENATOR (MODEL HFO)
K961530 · DTZ
Gish Biomedical, Inc.
Cardiovascular · 227d
Cleared Dec 05, 1996
CD HORIZON SPINAL SYSTEM
K961633 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 220d
Cleared Dec 05, 1996
WHISPER SWIVEL II EXHALATION PORT
K962203 · BZD
Respironics, Inc.
Anesthesiology · 181d
Cleared Dec 05, 1996
HEMAGEN ENA DSDNA KIT (EIA METHOD)
K962276 · DHN
Hemagen Diagnostics, Inc.
Immunology · 175d
Cleared Dec 05, 1996
GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
K962557 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 157d
Cleared Dec 05, 1996
NOVAGEL SILICONE GEL SHEETING
K963128 · MDA
Brennen Medical, Inc.
General & Plastic Surgery · 115d
Cleared Dec 05, 1996
BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY...
K963770 · JJY
Biocircuits Corp.
Chemistry · 77d
Cleared Dec 05, 1996
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
K963958 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 64d
Cleared Dec 05, 1996
TENET TIBIAL FRACTURE SUPPORT
K964102 · GBB
Tenet Medical Engineering
General & Plastic Surgery · 55d
Cleared Dec 05, 1996
VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES
K964175 · GEI
Valleylab, Inc.
General & Plastic Surgery · 48d
Cleared Dec 05, 1996
HUMERUS WIRES
K964243 · HSB
Compagnie Financiere & Medicale (Cf&M)
Orthopedic · 42d
Cleared Dec 04, 1996
XH-1 NEUROMUSCULAR STIMULATOR
K950550 · IPF
California Medical Research Institute
Physical Medicine · 672d
Cleared Dec 04, 1996
SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE
K952315 · DQA
Emg Scientific
Anesthesiology · 567d
Cleared Dec 04, 1996
FOOT WEIGHT ALARM
K962591 · IRN
Cleveland Medical Devices, Inc.
Physical Medicine · 155d
Cleared Dec 04, 1996
EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST
K963231 · JHI
Excel Scientific, Inc.
Chemistry · 107d
Cleared Dec 04, 1996
AMS AMBICOR PENILE PROSTHESIS
K963328 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 103d
Cleared Dec 04, 1996
CPI MODEL 6260, 6260A OR 6261 OIL-LESS ASPIRATOR
K963558 · JCX
Contemporary Products, Inc.
General & Plastic Surgery · 90d
Cleared Dec 04, 1996
POLAR CARE 300
K963596 · ILO
Breg, Inc.
Physical Medicine · 86d
Cleared Dec 04, 1996
STETHOS
K963621 · DQD
Theratechnologies, Inc.
Cardiovascular · 89d