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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
169897–169920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1979
INOCULATOR, MIC-2000 DISPOSABLE
K790076 · JTC
Dynatech Laboratories, Inc.
Microbiology · 20d
Cleared Feb 01, 1979
NEEDLE, BLOOD COLLECTING
K790079 · GAA
Jelco Laboratories
General & Plastic Surgery · 23d
Cleared Feb 01, 1979
LUBRICANT, OTRHO PERSONAL
K790087 · KMJ
Ortho Pharmaceutical Corp.
General Hospital · 15d
Cleared Feb 01, 1979
CATHETER TUBING MODIFICATION
K790107 · DQO
Jelco Laboratories
Cardiovascular · 16d
Cleared Feb 01, 1979
SCALE, DIGITAL CHAIR
K790130 · FRI
Acme Medical Scale Co.
General Hospital · 9d
Cleared Feb 01, 1979
CUFF CONNECTOR
K790148 · BZA
Airlife, Inc.
Anesthesiology · 20d
Cleared Feb 01, 1979
MASK INTULATION ADAPTOR
K790149 · BZA
Airlife, Inc.
Anesthesiology · 20d
Cleared Feb 01, 1979
BIRD DRIVE LINE ADAPTOR
K790150 · BYX
Airlife, Inc.
Anesthesiology · 20d
Cleared Feb 01, 1979
VENTILATOR ELBOW W/SUCTION PORT
K790155 · BZA
Airlife, Inc.
Anesthesiology · 20d
Cleared Feb 01, 1979
TRACH T ADAPTER
K790157 · BZA
Airlife, Inc.
Anesthesiology · 20d
Cleared Jan 31, 1979
MONITOR, BECKMAN LB-3CO2
K782138 · CCK
Beckman Instruments, Inc.
Anesthesiology · 35d
Cleared Jan 31, 1979
SPIROMETER, MINI POSITIVE
K782145 · BZK
Boehringer Laboratories
Anesthesiology · 35d
Cleared Jan 30, 1979
PULSE GENERATOR, CYBERLITH IMPLANTABLE
K790221
Intermedics, Inc.
Cardiovascular
Cleared Jan 29, 1979
CARDIAC COMPUTERS, CO-10 & CO-10R
K781805 · DXG
Waters Assoc., Inc.
Cardiovascular · 97d
Cleared Jan 26, 1979
VISION-STIMULATOR, CAM
K781313 · HPL
Clement Clarke, Inc.
Ophthalmic · 179d
Cleared Jan 26, 1979
POSITIVE PLACEMENT ANETHESIA KIT
K781469 · CAZ
Arrow Intl., Inc.
Anesthesiology · 151d
Cleared Jan 26, 1979
RIA KIT, QUANTITOPE CORTISOL
K781903 · CGR
Kallestad Laboratories, Inc.
Chemistry · 74d
Cleared Jan 26, 1979
GENTAMICIN FLUROIMMUNASSAY KIT
K782025 · LCQ
Technia Diagnostics , Ltd.
Toxicology · 52d
Cleared Jan 26, 1979
CORD, ENTEROBACTERIACEAE BIOCHEMICAL
K782056 · JSS
Vitek Systems, Inc.
Microbiology · 46d
Cleared Jan 26, 1979
MVS UNIT, MODEL SEU-8 AND DEU-8, 80
K782068 · EHZ
Dentsply Intl.
Dental · 44d
Cleared Jan 26, 1979
VENEER SYSTEM, MOSTIQUE LAMINATE
K782080 · KLE
Caulk Co., Div. Dentsply
Dental · 44d
Cleared Jan 26, 1979
INSTRUMENTS, OVERREFRACTION SYSTEM
K782096 · HLM
Zeiss Humphrey System
Ophthalmic · 39d
Cleared Jan 26, 1979
RIA KIT, GAMMACOAT
K782109 · CDX
Clinical Assays, Inc.
Chemistry · 38d
Cleared Jan 26, 1979
RIA KIT, RIANEN CORTISOL
K782110 · CGR
New England Nuclear
Chemistry · 38d