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
134473–134496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1988
OMNIGRAPH 6000
K880357 · DPS
Telemed Div.
Cardiovascular · 187d
Cleared Aug 02, 1988
CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
K880575 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 174d
Cleared Aug 02, 1988
SIEMENS INTRAVAGINAL TRANSDUCER
K881405 · HGL
Siemens Medical Solutions USA, Inc.
Obstetrics & Gynecology · 120d
Cleared Aug 02, 1988
SYSTEM5RH STATIONARY EXERCISE BICYCLE
K881475 · DPS
Combi Co. Ltd., C/O Mitsui & Co....
Cardiovascular · 117d
Cleared Aug 02, 1988
CATHETER STRAP
K881781 · KOD
Baxter Healthcare Corp
Gastroenterology & Urology · 98d
Cleared Aug 02, 1988
QLT ABSOLUTE URINE-HCG PREGNANCY TEST
K881806 · JHI
Quadra Logic Technologies, Inc.
Chemistry · 96d
Cleared Aug 02, 1988
MODEL MICRO SI AMBULATORY ECG MONITOR
K881905 · DSI
Advanced Medical Products, Inc.
Cardiovascular · 88d
Cleared Aug 02, 1988
EMIT HVA OPIATE ASSAY
K881941 · DJG
Syva Co.
Toxicology · 85d
Cleared Aug 02, 1988
ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM
K881981 · KOD
Ryder Intl. Corp.
Gastroenterology & Urology · 82d
Cleared Aug 02, 1988
MODIFICATION OF BEHRING RAPIMAT II/T
K882095 · JJQ
Behring Diagnostics, Inc.
Chemistry · 75d
Cleared Aug 02, 1988
MODEL 700 PATIENT MONITOR
K882118 · DRS
Ivy Biomedical Systems, Inc.
Cardiovascular · 75d
Cleared Aug 02, 1988
PANAMEX(TM) URETERAL STENT
K882157 · FAD
Kingston Technologies, Inc.
Gastroenterology & Urology · 71d
Cleared Aug 02, 1988
MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES
K882209 · CHL
Linde Div. Union Carbide Corp.
Chemistry · 68d
Cleared Aug 02, 1988
CALIBRATION KIT
K882220 · JIW
King Diagnostics, Inc.
Chemistry · 68d
Cleared Aug 02, 1988
D-CHEM
K882307 · JJE
Photec Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 02, 1988
TELEMETRIC STETHOSCOPE
K882319 · BZT
Vital Signs, Inc.
Anesthesiology · 57d
Cleared Aug 02, 1988
MODEL #825 ADULT STIM. PADS POLYMER TYPE
K882337 · LDD
Cardiotronics, Inc.
Cardiovascular · 57d
Cleared Aug 02, 1988
KOTEX LIGHTDAYS LONGS DEODORANT & REG. PANTILINERS
K882364 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 55d
Cleared Aug 02, 1988
RHYTHMSCAN HR HOLTER RECORDER
K882366 · DSH
Brentwood Instruments, Inc.
Cardiovascular · 55d
Cleared Aug 02, 1988
RESUBMITTED DIODE LASER COAGULATOR
K882372 · HQF
CooperVision, Inc.
Ophthalmic · 68d
Cleared Aug 02, 1988
DIAZO, COLORIMETRIC BILIRUBIN
K882459 · CIG
Tech-Neal Scientific, Inc.
Chemistry · 48d
Cleared Aug 02, 1988
ENZYMATIC CO2 REAGENT SET
K882497 · KHS
American Monitor Corp.
Chemistry · 46d
Cleared Aug 02, 1988
EMIT HVA AMPHETAMINE ASSAY
K882589 · DKZ
Syva Co.
Toxicology · 40d
Cleared Aug 02, 1988
TISSUE PUNCH
K882834 · EKJ
Tri-Stage, Inc.
Dental · 25d