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
156529–156552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1983
OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY
K837443
Medical Diagnostic Instruments, Inc.
Radiology · 42d
Cleared Jun 10, 1983
AUTOSECTOR
K837499
Technicare Corp.
Radiology · 32d
Cleared Jun 10, 1983
KODAK T-MAT G FILM SO-381
K837506
Eastman Kodak Company
Radiology · 29d
Cleared Jun 08, 1983
WEYLAND EXTENSION VIBRATOR
K822413 · JFB
Medical Management Service, Inc.
Physical Medicine · 302d
Cleared Jun 08, 1983
DISP. YANKAVER SURG. SUCTION INSTRUMENT
K830123 · GCY
Narco Scientific
General & Plastic Surgery · 148d
Cleared Jun 08, 1983
FLORET STRUNG GAUZE SPONGES
K830261 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 134d
Cleared Jun 08, 1983
FLORET KITTNER OR K DISSECTOR
K830266 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 134d
Cleared Jun 08, 1983
FLORET SPECIAL GAUZE SPONGES
K830267 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 134d
Cleared Jun 08, 1983
FLORET CYLINDRICAL/BRONCHOSCOPIC/LAMIN
K830268 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 134d
Cleared Jun 08, 1983
LIPOSOL
K830472 · JKA
Quest Medical, Inc.
Chemistry · 113d
Cleared Jun 08, 1983
BRAIN MODULE RJ-Z10
K830475 · CAI
Instrumentation Industries, Inc.
Anesthesiology · 113d
Cleared Jun 08, 1983
VITAL SIGNS MONITOR 2
K830587 · DRT
Physio-Control Corp.
Cardiovascular · 105d
Cleared Jun 08, 1983
HEPCOL SYSTEM B-10 & B-10-P
K830665 · JOX
Hemotec, Inc.
Hematology · 97d
Cleared Jun 08, 1983
CRAFON ARTHROSCOPY LINES
K830673 · HRX
Gambro, Inc.
Orthopedic · 96d
Cleared Jun 08, 1983
LS-1 PORTABLE BLOOD PRESSURE COMPUTER
K830713 · DXN
Vita-Stat Medical Services, Inc.
Cardiovascular · 92d
Cleared Jun 08, 1983
ALPHAMEDIX I/A HAND-PIECE, 500-001
K830812 · HQC
Alphamedix, Inc.
Ophthalmic · 85d
Cleared Jun 08, 1983
LEGIONELLA DFA KIT I
K830820 · LHL
Bionetic Laboratory Products
Immunology · 85d
Cleared Jun 08, 1983
LAVATORY SEAT HEIGHTENER
K830853 · ILS
Lic-Orthion
Physical Medicine · 83d
Cleared Jun 08, 1983
BIO-PROBE SYSTEM-BLOOD FLOW PROBE
K830858 · DPT
Bio Medicus, Inc.
Cardiovascular · 83d
Cleared Jun 08, 1983
AP-CHECK
K830877 · GYA
General Devices
Neurology · 82d
Cleared Jun 08, 1983
BICARBONATE/VARIABLE SODIUM KIT-DM-367
K830908 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 79d
Cleared Jun 08, 1983
DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON
K831012 · CHL
Fisher Scientific Co., LLC
Chemistry · 70d
Cleared Jun 08, 1983
DIAGNOSTICS PO 2 ELECTROLYTE
K831013 · CHL
Fisher Scientific Co., LLC
Chemistry · 70d
Cleared Jun 08, 1983
HEMOGLOBIN ELECTROPHORESIS METH ON THE-
K831055 · JBO
Olympus Corp.
Hematology · 68d