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
157297–157320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1983
STERILE SAFETY PINS
K830381 · GAZ
Devon Industries, Inc.
General Hospital · 48d
Cleared Mar 24, 1983
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
K830390 · DXY
Telectronics, Inc.
Cardiovascular · 42d
Cleared Mar 24, 1983
ECLIPSE
K830407 · DSI
Diagnostic Medical Instruments
Cardiovascular · 45d
Cleared Mar 24, 1983
TITANALOY SUBMERSIBLE IMPLANT SYSTEM
K830414 · DZE
Boehringer/Miter, Inc.
Dental · 44d
Cleared Mar 24, 1983
RESPI-NEB-AEROSOL SYSTEM
K830417 · BTI
Professional Medical Supply, Inc.
Anesthesiology · 44d
Cleared Mar 24, 1983
CENTRAL STATION 590
K830432 · DRT
Kone Instruments, Inc.
Cardiovascular · 43d
Cleared Mar 24, 1983
PATIENT MONITOR 575
K830433 · DRT
Kone Instruments, Inc.
Cardiovascular · 43d
Cleared Mar 24, 1983
OXYGEN MONITOR OHIO 5100
K830446 · CCL
Airco/Ohio Medical Products
Anesthesiology · 42d
Cleared Mar 24, 1983
KINETIC CREATININE
K830447 · CGX
American Monitor Corp.
Chemistry · 42d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
K830460 · DOE
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE
K830461 · KXS
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOUMMUNOASSAY--URINE
K830462 · DOE
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
BILIRUBIN STANDARD-LYOPHILIZED
K830469 · JIT
Dow Instruments & Reagents, Inc.
Chemistry · 37d
Cleared Mar 24, 1983
ANESTHESIA BREATHING CIRCUITS
K830470 · CAI
Mon-A-Therm, Inc.
Anesthesiology · 37d
Cleared Mar 24, 1983
KELLY-WICK TANNELER
K830471 · DWS
Intl. Medical Prosthetics Research
Cardiovascular · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-COCAINE META
K830480 · KLN
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
K830481 · LCL
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE
K830482 · DJP
Hoffmann-La Roche, Inc.
Toxicology · 37d
Cleared Mar 24, 1983
OMED IDENT-I-BAND
K830484
Omega-Med Intl., Inc.
General & Plastic Surgery · 37d
Cleared Mar 24, 1983
NOVA 8 IONIZED CALCIUM/PH ANALYZER
K830502 · JFP
Nova Biomedical Corp.
Chemistry · 36d
Cleared Mar 24, 1983
PRECISION EEG CAP W/ELECTRODE SET AND
K830521 · GXY
Precision Cap Systems
Neurology · 35d
Cleared Mar 24, 1983
HENKE JECT PRESSURE SYRINGE
K830524 · EJI
Smith & Nephew, Mpl Division
Dental · 35d
Cleared Mar 24, 1983
BIOFEEDBACK-TRAINING INSTRUMENT
K830529 · HCC
Relaxomat, Inc.
Neurology · 34d
Cleared Mar 24, 1983
FLOW-PAC ALKALINE PHOSPHATE REAGENT SET
K830535 · CJF
Amresco, Inc.
Chemistry · 34d