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
154969–154992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 1983
PERMALUX VISIBLE CURE COMPOSITE RESTOR
K831351 · EBF
Lares Manufacturing Co., Inc.
Dental · 203d
Cleared Nov 14, 1983
SINGLE BED ARRHYTHMIA MONITOR AM500
K831638 · DSI
Lifeline Systems, Inc.
Cardiovascular · 175d
Cleared Nov 14, 1983
ELECTRO-PULSE
K832160 · GZJ
Electro-Pulse
Neurology · 132d
Cleared Nov 14, 1983
PERIPHERAL TRANSLUMINAL ARGIOPLASTY
K832279
Sontek Corp.
General & Plastic Surgery · 125d
Cleared Nov 14, 1983
BP TRANSDUCER HOLDERS TH-2,3 & 4
K832384 · DXO
American Bentley
Cardiovascular · 118d
Cleared Nov 14, 1983
ENCODYNE 4 & VACUFIX 4
K832393
Elmed, Inc.
Neurology · 118d
Cleared Nov 14, 1983
TRANCOJECT DISPOSABLE SYRINGES
K832605 · FMF
Huborga, Inc.
General Hospital · 103d
Cleared Nov 14, 1983
BETA SCAN REAGENT STRIP
K832691 · CGA
Orange Medical Instruments, Inc.
Hematology · 96d
Cleared Nov 14, 1983
PNEU PAC VENTILATOR/RESUSCITATORS
K832700 · CBK
Pneupac , Ltd.
Anesthesiology · 96d
Cleared Nov 14, 1983
FOAM HELMET - USE W/ESOPHAGEAL TAMPONA
K832859 · KNT
Inmed Corp.
Gastroenterology & Urology · 83d
Cleared Nov 14, 1983
IMMUNOENZYME TEST SYS-DETECT-IGM ANTI
K832900 · GLZ
Bionetic Laboratory Products
Immunology · 77d
Cleared Nov 14, 1983
DEFAZOLIN 30MCG. SENSITIVITY DISCS
K832910 · JTN
Difco Laboratories, Inc.
Immunology · 77d
Cleared Nov 14, 1983
PRIMA-UNIPOLAR CARDIAC PULSE GENERAT
K832914 · DXY
Intermedics, Inc.
Cardiovascular · 77d
Cleared Nov 14, 1983
INIVOX ELECTRODE/CATHETER SYS
K832916 · LLE
Critikon Company, LLC
Neurology · 77d
Cleared Nov 14, 1983
PACEMAKER SYS. ANALYZER 378
K832959 · KRE
Siemens Elema AB
Cardiovascular · 76d
Cleared Nov 14, 1983
BACTERUERIA SCREENING PROCEDURE
K832975 · JXA
Turner Designs, Inc.
Microbiology · 74d
Cleared Nov 14, 1983
SOFFBAN ORTHOPEDIC PADDING
K832992 · ITG
Smith & Nephew, Inc.
Physical Medicine · 73d
Cleared Nov 14, 1983
PARAMAX BILIRUBIN CALIBRATORS
K833005 · JIX
American Dade
Chemistry · 94d
Cleared Nov 14, 1983
RXG
K833052 · EJT
Jeneric Ind.
Dental · 68d
Cleared Nov 14, 1983
Y CERAMIC
K833053 · EJT
Jeneric Ind.
Dental · 68d
Cleared Nov 14, 1983
LARYNGOSCOPE BLADES/HANDLES & LAMPS
K833055 · CCW
Medovations, Inc.
Anesthesiology · 68d
Cleared Nov 14, 1983
TDX THEOPHYLLINE
K833070 · LER
Abbott Laboratories
Toxicology · 67d
Cleared Nov 14, 1983
TECHNICON RA-1000 SYS-ISE MODULE &
K833072 · JGS
Technicon Instruments Corp.
Chemistry · 67d
Cleared Nov 14, 1983
RIONET HEARING AID HB-345
K833134 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 62d