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
119833–119856 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1991
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K912669 · EWO
Resound Corp.
Ear, Nose, Throat · 90d
Cleared Sep 16, 1991
WHITER BITER CROWN
K912686 · ELZ
George M. Wilson, Dds
Dental · 90d
Cleared Sep 16, 1991
TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL
K912696 · IYB
Bennett X-Ray Corp.
Radiology · 90d
Cleared Sep 16, 1991
SATIN PROPHYLAXIS PASTE
K912945 · EJR
Dentsply Intl.
Dental · 73d
Cleared Sep 16, 1991
BACTIDROP(TM) LACTOPHENOL ANILINE BLUE
K913005 · JIO
Remel Co.
Hematology · 70d
Cleared Sep 16, 1991
MED-E-JET INJECTOR
K913018 · KZE
Med-E-Jet D
General Hospital · 69d
Cleared Sep 16, 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10
K913062 · IZO
Shimadzu Medical Systems
Radiology · 68d
Cleared Sep 16, 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10
K913063 · IZO
Shimadzu Medical Systems
Radiology · 68d
Cleared Sep 16, 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L
K913064 · IZO
Shimadzu Medical Systems
Radiology · 68d
Cleared Sep 16, 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L
K913065 · IZO
Shimadzu Medical Systems
Radiology · 68d
Cleared Sep 16, 1991
LEG URINAL
K913155 · GAQ
Ezmt Valve Co., Inc.
General & Plastic Surgery · 61d
Cleared Sep 16, 1991
EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS
K913410 · DMB
Syva Co.
Toxicology · 47d
Cleared Sep 16, 1991
HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE
K913564 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 38d
Cleared Sep 16, 1991
5MM MICROSCISSORS
K913870 · GCJ
Endovations
General & Plastic Surgery · 18d
Cleared Sep 13, 1991
DIPSTICK SALMONELLA
K910438 · GRM
Ampcor, Inc.
Microbiology · 225d
Cleared Sep 13, 1991
DENTAL NEEDLE PROTECTIVE SYSTEM
K910475 · DZM
Health Technology Systems, Inc.
Dental · 219d
Cleared Sep 13, 1991
CONTROL AND LINEARITY
K910881 · DKB
Gds Diagnostics
Chemistry · 196d
Cleared Sep 13, 1991
AMB-ALERT
K911079 · KMI
Medway
General Hospital · 186d
Cleared Sep 13, 1991
SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER
K911626 · GKZ
Serono Baker Diagnostics System
Hematology · 155d
Cleared Sep 13, 1991
AIR ARGON ION LASERS VARIOUS MODELS
K912628 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 88d
Cleared Sep 13, 1991
ATRIUMS PDR THORACIC CATHETER
K912645 · GBS
Atrium Medical Corp.
General & Plastic Surgery · 88d
Cleared Sep 13, 1991
MINIMAX OXYGENATION SYSTEM
K912655 · DTZ
Medtronic Vascular
Cardiovascular · 88d
Cleared Sep 13, 1991
INTHERM RADIALLY EXPANDING DILATER
K912971 · FGE
Interventional Therapeutics Corp.
Gastroenterology & Urology · 67d
Cleared Sep 13, 1991
X-L (DW228-14A) AND X-LX (DW228-24A)
K913070 · EJS
Ivoclar North America, Inc.
Dental · 64d