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
99697–99720 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1995
SPINAL PEDICLE SCREW, FIXATION, APPLIANCE
K952298 · MNH
J.B.S., S.A.
Orthopedic · 211d
Cleared Dec 13, 1995
VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE
K952645 · FOZ
Vital Signs, Inc.
General Hospital · 187d
Cleared Dec 13, 1995
RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)
K952766 · HRS
Creative Medical Designs, Inc.
Orthopedic · 196d
Cleared Dec 13, 1995
THE NINER NITINOL GUIDEWIRE
K952860 · DQX
Microvena Corp.
Cardiovascular · 174d
Cleared Dec 13, 1995
VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE
K953120 · FOZ
Vital Signs, Inc.
General Hospital · 161d
Cleared Dec 13, 1995
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)
K953731 · FRN
Abbott Laboratories
General Hospital · 127d
Cleared Dec 13, 1995
ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION...
K954300 · FOS
Sherwood Medical Co.
General Hospital · 90d
Cleared Dec 13, 1995
ALTA TIBIAL/HUMERAL ROD
K954554 · HSB
Howmedica Corp.
Orthopedic · 72d
Cleared Dec 13, 1995
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
K954630 · JDW
Depuy, Inc.
Orthopedic · 68d
Cleared Dec 13, 1995
CIBA CORNING ACS ESTRADIOL-6 ASSAY
K954697 · CHP
Ciba Corning Diagnostics Corp.
Chemistry · 62d
Cleared Dec 13, 1995
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
K954799 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 56d
Cleared Dec 13, 1995
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
K954809 · LDF
Medtronic Vascular
Cardiovascular · 55d
Cleared Dec 13, 1995
QUIX RAPID PREGNANCY STRIP TEST
K954993 · JHI
Guardian Scientific, Corp.
Chemistry · 43d
Cleared Dec 13, 1995
EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS
K955001 · GEI
Everest Medical Corp.
General & Plastic Surgery · 41d
Cleared Dec 13, 1995
CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
K955042 · DCN
Shared Systems, Inc.
Immunology · 40d
Cleared Dec 13, 1995
ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT
K955089 · EMA
Wallace A. Erickson & Co.
Dental · 36d
Cleared Dec 13, 1995
CARBAMAZEPINE EIA TEST
K955100 · KLT
Diagnostic Reagents, Inc.
Toxicology · 35d
Cleared Dec 13, 1995
ANTI-EM/GP STOCKINGS
K955138 · DWL
Jobst Institute, Inc.
General Hospital · 30d
Cleared Dec 13, 1995
AELITEFLO
K955292 · EBF
Bisco, Inc.
Dental · 26d
Cleared Dec 13, 1995
SPYROCOLLOID WOUND DRESSING
K955383 · MGP
Polymedica Industries, Inc.
General & Plastic Surgery · 19d
Cleared Dec 12, 1995
DISPOSABLE ECG MONITORING ELECTRODE
K950473 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 312d
Cleared Dec 12, 1995
URINARY GEL DRAINAGE SYSTEM
K952780 · EYZ
P.A.M., Inc.
Gastroenterology & Urology · 179d
Cleared Dec 12, 1995
AP-18
K953642 · JEH
Jeneric/Pentron, Inc.
Anesthesiology · 130d
Cleared Dec 12, 1995
AMOXICILLIN/CLAVULANIC ACID 2/1
K954319 · JWY
Ab Biodisk
Microbiology · 90d