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
73777–73800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2002
SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
K022409 · JHT
Spectral Diagnostics, Inc.
Chemistry · 68d
Cleared Sep 30, 2002
CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
K022512 · GKH
Immunicon Corp.
Hematology · 62d
Cleared Sep 30, 2002
LDL CHOLESTEROL (AUTOMATED)
K022519 · JHM
Jas Diagnostics, Inc.
Chemistry · 62d
Cleared Sep 30, 2002
FASTPACK TESTOSTERONE CALIBRATOR
K022533 · JIT
Qualigen, Inc.
Chemistry · 61d
Cleared Sep 30, 2002
HARMONY INR MONITORING SYSTEM
K022922 · GJS
Lifescan, Inc.
Hematology · 26d
Cleared Sep 30, 2002
GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT
K023062 · FRN
Abbott Laboratories, Inc.
General Hospital · 14d
Cleared Sep 27, 2002
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE
K013875 · IXI
Med-Tec,Inc.
Radiology · 308d
Cleared Sep 27, 2002
DAYTRIPPER DIALYSATE WARMER
K020542 · MLW
Stickman Industries, Inc.
Gastroenterology & Urology · 220d
Cleared Sep 27, 2002
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
K021266 · KNS
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 158d
Cleared Sep 27, 2002
EBV EA-D IGG ELISA KIT, MODEL EBG-100
K021793 · LSE
Pan Bio Pty. , Ltd.
Microbiology · 119d
Cleared Sep 27, 2002
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K021814 · MMI
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Sep 27, 2002
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
K022103 · BZG
Puritan Bennett Corp.
Anesthesiology · 91d
Cleared Sep 27, 2002
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
K022115 · DTZ
Terumo Corp.
Cardiovascular · 88d
Cleared Sep 27, 2002
GLOBAL ECG MANAGEMENT SYSTEM (GEMS)
K022297 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 73d
Cleared Sep 27, 2002
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162,...
K022424 · DZE
Nobel Biocare Uas, Inc.
Dental · 65d
Cleared Sep 27, 2002
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K022552 · DQY
Cook, Inc.
Cardiovascular · 56d
Cleared Sep 27, 2002
M2 SINGLE USE MICROKERTOME
K022560 · HMY
Moria SA
Ophthalmic · 56d
Cleared Sep 27, 2002
PH AND AMINES EXTERNAL CONTROL SET
K022851 · JJY
Quidel Corp.
Chemistry · 31d
Cleared Sep 27, 2002
HRK-63 KNEE ARRAY COIL
K022883 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Sep 27, 2002
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
K022901 · JIS
Ortho-Clinical Diagnostics
Chemistry · 24d
Cleared Sep 26, 2002
AXIAMED TRANS-SACRAL SPINAL ACCESS DEVICE
K020457 · HRX
Axiamed, Inc.
Orthopedic · 227d
Cleared Sep 26, 2002
DOCXS B SERIES ELECTRODES
K020903 · GXY
Docxs, LLC
Neurology · 190d
Cleared Sep 26, 2002
CHLORAPREP
K021131 · LBH
Centrix, Inc.
Dental · 171d
Cleared Sep 26, 2002
ATLAS MONITOR, MODELS 200,210,220
K022084 · DQA
Welch Allyn, Inc.
Anesthesiology · 91d