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
114553–114576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1993
NON-INVASIVE TUBING
K921450 · FPK
Specialty Medical Sales, Inc.
General Hospital · 316d
Cleared Feb 05, 1993
MEDICAM 900 INSUFFLATOR WITH ACCESSORIES
K921837 · HIF
Kirschner Medical Corp.
Obstetrics & Gynecology · 294d
Cleared Feb 05, 1993
ILLUMINATOR II
K922277 · KZF
Medical Illumination, Inc.
General Hospital · 266d
Cleared Feb 05, 1993
ILLUMINATOR VII MINI/LUM LIGHT
K922280 · KZF
Medical Illumination, Inc.
General Hospital · 266d
Cleared Feb 05, 1993
ILLUMINATOR VII MINI/SPOT LIGHT
K922281 · KZF
Medical Illumination, Inc.
General Hospital · 266d
Cleared Feb 05, 1993
INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE
K922382 · MEB
Baxter Healthcare Corp
General Hospital · 261d
Cleared Feb 05, 1993
CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1
K922744 · GKZ
Coulter Immunology
Hematology · 242d
Cleared Feb 05, 1993
CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1
K922745 · GKZ
Coulter Immunology
Hematology · 242d
Cleared Feb 05, 1993
IL TEST CALIBRATION SET APO A1B
K923079 · DFC
Instrumentation Laboratory CO
Immunology · 225d
Cleared Feb 05, 1993
URODYNAMIC CATHETERS
K923464 · FAP
R.L. Medical Corp.
Gastroenterology & Urology · 206d
Cleared Feb 05, 1993
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
K923762 · BTM
Ambu, Inc.
Anesthesiology · 192d
Cleared Feb 05, 1993
CELLEXIS HEMATOLOGY ANALYZER
K923773 · GKZ
Technalysis, Inc.
Hematology · 196d
Cleared Feb 05, 1993
PLEATMAN SAC SPECIMEN CONTAINER
K923945 · GCJ
Cabot Medical Corp.
General & Plastic Surgery · 185d
Cleared Feb 05, 1993
HISTOFREEZER
K924114 · GEH
Solarcare Technologies Corp,Inc.
General & Plastic Surgery · 184d
Cleared Feb 05, 1993
OPTILINK(TM) LPM (LASER POWER MODULATOR)
K924166 · GEX
Xintec Corporation
General & Plastic Surgery · 170d
Cleared Feb 05, 1993
ISOLETTE INCUBATOR HUMIDITY METER
K924170 · FMZ
Air-Shields, Inc.
General Hospital · 170d
Cleared Feb 05, 1993
ILS(TM) - INVASIVE LINE SEPARATOR
K924369 · KMK
2-Rn Corp.
General Hospital · 161d
Cleared Feb 05, 1993
RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE
K924443 · IZF
Control-X, Inc.
Radiology · 157d
Cleared Feb 05, 1993
B-4 FOUR-WAY RADIOGRAPHIC TABLE
K924444 · IZZ
Control-X, Inc.
Radiology · 157d
Cleared Feb 05, 1993
MASTERSTIM I-2
K924490 · LIH
Health Care Assoc.
Neurology · 155d
Cleared Feb 05, 1993
PERSONNA SAFETY SCALPEL
K924503 · MDM
American Safety Razor Co.
General & Plastic Surgery · 154d
Cleared Feb 05, 1993
CABOT MEDICAL NIAGARA(TM) 3.0 LITER HIGH FLOW IRRI
K924530 · HET
Cabot Medical Corp.
Obstetrics & Gynecology · 150d
Cleared Feb 05, 1993
PSA ANTIBODY KIT
K924578 · DFD
Ventana Medical Systems, Inc.
Immunology · 148d
Cleared Feb 05, 1993
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
K924703 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 141d