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
159865–159888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1982
LOW VOLUME INFUSTION SET
K821624 · FPA
Lifemed of California
General Hospital · 20d
Cleared Jun 22, 1982
GAS CHEX PLASTIC BAG
K821648 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 18d
Cleared Jun 22, 1982
FLEXIFLO-II
K821661 · FRN
Abbott Laboratories
General Hospital · 18d
Cleared Jun 22, 1982
SPINCHEM ACID PHOSPHATASE REAGENT
K821674 · CKB
Smithkline Diagnostics, Inc.
Hematology · 15d
Cleared Jun 22, 1982
CALCITONIN RIA TEST KIT, DLS 1200
K821675 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 14d
Cleared Jun 22, 1982
THE COMMUNICATOR
K821677 · ILQ
Robert Swinney. , Ltd.
Physical Medicine · 14d
Cleared Jun 22, 1982
TITAN GEL HIGH RESOLUTION SERUM PROTEIN
K821688 · JJN
Helena Laboratories
Chemistry · 14d
Cleared Jun 22, 1982
ERIKA HPF 100,200,300 DIALYZER
K821690 · FJI
Erika, Inc.
Gastroenterology & Urology · 14d
Cleared Jun 22, 1982
TDX NETILMICIN
K821698 · LCE
Abbott Laboratories
Chemistry · 14d
Cleared Jun 22, 1982
MGN CONDUCTIVE CONNECTING TUBE, STERILE
K821703 · BYY
Mgn Medical Manufacturing, Inc.
General Hospital · 20d
Cleared Jun 22, 1982
SERIES 10 LIQUID CHROMOTOGRAPH
K821727 · LDM
The Perkin-Elmer Corp.
Toxicology · 11d
Cleared Jun 21, 1982
SURGICAL UTILITY DRAPE
K821313 · FJZ
Megaplast, Inc.
Gastroenterology & Urology · 48d
Cleared Jun 21, 1982
LIGHT WEIGHT ALUMINUM CRUTCHES
K821403 · IPR
Manuco Manufacturing Co., Inc.
Physical Medicine · 41d
Cleared Jun 21, 1982
CERVITRAC TRACTION FRAME & CORD
K821522 · HST
George W. Cottrell
Neurology · 35d
Cleared Jun 21, 1982
ARGYLE VAC-U-CARE 100CC SUCTION RESERV
K821563 · GCY
Sherwood Medical Co.
General & Plastic Surgery · 27d
Cleared Jun 21, 1982
DISPOSABLE HEMOSTATS
K821617 · HRQ
Medcare Products
General & Plastic Surgery · 19d
Cleared Jun 21, 1982
DISPOSABLE NEEDLE HOLDERS
K821618 · FZX
Medcare Products
General & Plastic Surgery · 19d
Cleared Jun 21, 1982
STERILE SURGICAL DRAPES
K821666 · FJZ
Phoenix Glove Co.
Gastroenterology & Urology · 14d
Cleared Jun 18, 1982
AUTOMATIC EXPOSURE CONTROL TYPE A3300
K827525
Advanced Instrument Development, Inc.
Radiology · 28d
Cleared Jun 17, 1982
MEDTRONIC A-V PACING SYSTEM ANALYZER
K812262 · DTC
Medtronic Vascular
Cardiovascular · 308d
Cleared Jun 17, 1982
ARTERIAL BLOOD FILTER MODEL #AF-1040
K820343 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 129d
Cleared Jun 17, 1982
PEDIATRIC ARTERIAL BLOOD FILTER #AF-540
K820679 · DTM
Bentley Laboratories, Inc.
Cardiovascular · 98d
Cleared Jun 17, 1982
CR-9
K821223 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 51d
Cleared Jun 17, 1982
EXERCISE ECG ELECTRODES, REUSABLE
K821384 · DRG
Respironics, Inc.
Cardiovascular · 38d