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
149089–149112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1985
STAR 66F-AGC-I HEARING AID
K850190 · ESD
Robert Bosch Corp.
Ear, Nose, Throat · 66d
Cleared Mar 25, 1985
HEARING AID 365
K850243 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 62d
Cleared Mar 25, 1985
PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY
K850263 · BSJ
Plasmedics, Inc.
Anesthesiology · 61d
Cleared Mar 25, 1985
EMERGENCY ROOM PACK
K850338
Marwood Medical, Inc.
General & Plastic Surgery · 56d
Cleared Mar 25, 1985
AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG
K850344 · EGS
Midwest
Dental · 56d
Cleared Mar 25, 1985
AUTOMATIC IMPEDANCE METER TA-7A
K850461 · ETY
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 47d
Cleared Mar 25, 1985
MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL
K850597 · EFB
Micro-Aire Surgical Instruments, Inc.
Dental · 38d
Cleared Mar 25, 1985
CURAY JOIN DENT DENTIN PRIMER
K850675 · EBD
Scientific Pharmaceuticals, Inc.
Dental · 32d
Cleared Mar 25, 1985
SAF T FLO VENTILATOR TUBING
K850703 · BZO
Bivona Medical Technologies
Anesthesiology · 32d
Cleared Mar 25, 1985
CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL
K850724 · KZI
Rapid City Regional Hospital, Inc.
Microbiology · 31d
Cleared Mar 25, 1985
EARETTE HEARING AID OTICON MODEL E32S
K850762 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Mar 25, 1985
EARETTE HEARING AID OTICON E32U
K850763 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Mar 25, 1985
BRONCHITRAC L
K850784 · BSY
Ackrad Laboratories
Anesthesiology · 27d
Cleared Mar 25, 1985
DIAFLEX OCCLUSION BALLOON CATHETER
K850790 · KOD
American Edwards Laboratories
Gastroenterology & Urology · 27d
Cleared Mar 25, 1985
CORNING BLOOD COLLECTION CAPILLARY TUBES
K850806 · GIO
Corning Medical & Scientific
Hematology · 26d
Cleared Mar 25, 1985
COBAS FP REAGENTS FOR QUINIDINE
K850808 · LBZ
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Mar 25, 1985
MCCOY'S 5A M9270 W/L-GLUTAMINE & W/O PHENOL RED &
K850890 · KIT
Sigma Chemical Co.
Microbiology · 21d
Cleared Mar 25, 1985
DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT
K850891 · KIT
Sigma Chemical Co.
Microbiology · 21d
Cleared Mar 25, 1985
TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA
K850908 · JTC
Flow Laboratories, Inc.
Microbiology · 20d
Cleared Mar 25, 1985
SPRAYFIX
K850916 · PPM
Surgipath Medical Industries, Inc.
Pathology · 20d
Cleared Mar 25, 1985
MEM, M7270, W/EBSS, L-GLUTAMINE & W/O L-LEUCINE -
K850921 · KIT
Sigma Chemical Co.
Microbiology · 20d
Cleared Mar 25, 1985
MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL
K850922 · KIT
Sigma Chemical Co.
Microbiology · 20d
Cleared Mar 25, 1985
DUPONT PREP TYPE SI EXTRACITON CARTRIDGE
K850963 · DJY
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 17d
Cleared Mar 25, 1985
FLEXUS 2 CO2 SURGICAL LASER SYSTEM
K850985 · GEX
Intl. Solarium Manufacturer, Inc.
General & Plastic Surgery · 14d