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
163297–163320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1981
MEDAID
K810841 · GZJ
C.V.I., Inc.
Neurology · 77d
Cleared Jun 12, 1981
MINITONE
K810975 · IPF
Bloomex International, Inc.
Physical Medicine · 63d
Cleared Jun 12, 1981
PREFILLED PULSATOR SYRINGE
K811009 · FMF
Concord Laboratories, Inc.
General Hospital · 58d
Cleared Jun 12, 1981
SYPHGMOLOG
K811079 · DSK
Cardiodyne General, Inc.
Cardiovascular · 52d
Cleared Jun 12, 1981
IV SETS
K811107 · FPA
Critikon Company, LLC
General Hospital · 50d
Cleared Jun 12, 1981
DEL MAR AVIONICS MODELS 9400 & 9401
K811122 · DSI
Del Mar Avionics
Cardiovascular · 49d
Cleared Jun 12, 1981
SECHRIST INFANT VENTRILATOR MODEL IV-100
K811141 · CBK
Sechrist Industries, Inc.
Anesthesiology · 46d
Cleared Jun 12, 1981
KERMATH RADIOGRAPHIC HEAD STAND
K811215 · KPR
Kermath Mfg. Corp.
Radiology · 39d
Cleared Jun 12, 1981
HUMAN BLOOD IN ALSEVER'S
K811225 · JSK
Dutchland Laboratories, Inc.
Pathology · 39d
Cleared Jun 12, 1981
CATHETER MAINTENANCE KIT
K811247 · FRG
Clinipad Corp.
General Hospital · 38d
Cleared Jun 12, 1981
GC CULTURE MEDIUM
K811281 · JTY
Biolog, Inc.
Microbiology · 35d
Cleared Jun 12, 1981
SELECTIVE GC CULTURE MEDIUM
K811282 · JTY
Biolog, Inc.
Microbiology · 35d
Cleared Jun 12, 1981
JEMBEC TRANSPORT SYSTEM
K811283 · JTW
Biolog, Inc.
Microbiology · 35d
Cleared Jun 12, 1981
GC TTANSPORT SYSTEM
K811284 · JTW
Biolog, Inc.
Microbiology · 35d
Cleared Jun 12, 1981
GAMBRO PERITONEAL DIALYSIS FLUID LINES
K811294 · KDJ
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared Jun 12, 1981
BI-CRP LATEX TEST
K811374 · DCN
Biologics Intl., Inc.
Microbiology · 28d
Cleared Jun 12, 1981
BI-RA SLIDE TEST
K811375 · DHR
Biologics Intl., Inc.
Microbiology · 28d
Cleared Jun 12, 1981
CEA DESALTING DOLUMN SEPHADEX R
K811394 · DHX
Immuno-Diagnostic Laboratories
Chemistry · 25d
Cleared Jun 12, 1981
AXICARE BREAST PUMP MODEL
K811403 · HGX
Neonatal Corp.
Obstetrics & Gynecology · 25d
Cleared Jun 12, 1981
STERILIZATION INDICATOR/SEAL PROTECTOR
K811408 · JOJ
Beacon Converters, Inc.
General Hospital · 24d
Cleared Jun 12, 1981
MEDI-TRACE
K811410 · KRA
Graphic Controls Corp.
Cardiovascular · 24d
Cleared Jun 12, 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · KRB
American Edwards Laboratories
Cardiovascular · 24d
Cleared Jun 12, 1981
BAIM CORONARY SINUS FLOW ANALYZER
K811414 · DXG
Electro-Catheter Corp.
Cardiovascular · 24d
Cleared Jun 12, 1981
SPRIO-LOOP
K811419 · BTX
Datamed, Inc.
General & Plastic Surgery · 24d