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
75385–75408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2002
AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING...
K014168 · IYN
Biosound Esaote, Inc.
Radiology · 127d
Cleared Apr 25, 2002
ISAAC 1.5 T MR SYSTEM
K020268 · LNH
Chi, Inc.
Radiology · 90d
Cleared Apr 25, 2002
ATRION MEDICAL QL FLUID DISPENSING SYRINGE
K020333 · DXT
Atrion Medical Products, Inc.
Cardiovascular · 84d
Cleared Apr 25, 2002
PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
K020708 · DPS
Philips Medical Systems, Inc.
Cardiovascular · 51d
Cleared Apr 25, 2002
SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF...
K021005 · FPA
Sterling Medivations, Inc.
General Hospital · 28d
Cleared Apr 25, 2002
S2 FEMORAL NAIL
K021026 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 25, 2002
S2 TIBIAL NAIL
K021027 · HSB
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Apr 24, 2002
LYMPHA VISION-EXPERT
K003896 · GXY
Bexley Trading, Inc.
Neurology · 492d
Cleared Apr 24, 2002
DATASCOPE'S 8FR. ALT B IAB
K020257 · DSP
Datascope Corp.
Cardiovascular · 90d
Cleared Apr 24, 2002
MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
K020289 · LNH
Machnet BV
Radiology · 86d
Cleared Apr 24, 2002
AGC SPEZIALLEGIERUNG
K020347 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 79d
Cleared Apr 24, 2002
JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
K020515 · DWF
Jostra AG
Cardiovascular · 68d
Cleared Apr 24, 2002
POLYMEDCO HBA1C TEST
K020532 · LCP
Polymedco, Inc.
Hematology · 64d
Cleared Apr 24, 2002
SIMPLICITY
K020570 · KLE
Apex Dental Materials, Inc.
Dental · 62d
Cleared Apr 24, 2002
FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
K020601 · MOS
Odin Medical Technologies , Ltd.
Radiology · 61d
Cleared Apr 24, 2002
H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE...
K020954 · LKF
Ackrad Laboratories
Obstetrics & Gynecology · 30d
Cleared Apr 24, 2002
MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
K021103 · LKJ
Zeus Scientific, Inc.
Immunology · 19d
Cleared Apr 23, 2002
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
K012387 · BZM
Stethographics, Inc.
Anesthesiology · 270d
Cleared Apr 23, 2002
DIASOL-BICARB
K020230 · KPO
Diasol, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 23, 2002
NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
K020300 · KPS
Syntermed, Inc.
Radiology · 84d
Cleared Apr 23, 2002
INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL,...
K020495 · MOS
Surgi-Vision, Inc.
Radiology · 68d
Cleared Apr 23, 2002
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · JEY
Synthes (Usa)
Dental · 67d
Cleared Apr 23, 2002
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
K020604 · DWJ
Nellcor Puritan Bennett, Inc.
Cardiovascular · 57d
Cleared Apr 23, 2002
ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM...
K020838 · LYY
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 40d