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
89713–89736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1998
ENVOY PATIENT MONITOR
K974510 · DSI
Mennen Medical, Inc.
Cardiovascular · 134d
Cleared Apr 14, 1998
UNIVERSITY PLATE ANTERIOR SYSTEM
K980228 · KWQ
Acromed Corp.
Orthopedic · 82d
Cleared Apr 14, 1998
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
K980368 · HRS
Depuy, Inc.
Orthopedic · 74d
Cleared Apr 14, 1998
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
K980370 · KTT
Biomet, Inc.
Orthopedic · 74d
Cleared Apr 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K980447 · MNH
DePuy Orthopaedics, Inc.
Orthopedic · 68d
Cleared Apr 14, 1998
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
K980486 · JDI
Implex Corp.
Orthopedic · 64d
Cleared Apr 14, 1998
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980496 · MNH
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Apr 14, 1998
ARTICUL/EZE FEMORAL HEADS
K980513 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Apr 14, 1998
DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
K980543 · EHD
Dentsply Intl.
Radiology · 61d
Cleared Apr 14, 1998
AR SAFE NITRILE EXAMINATION GLOVES
K980589 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 56d
Cleared Apr 14, 1998
LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE)
K980605 · LYY
Pt. Sarana Indoprotex
General Hospital · 56d
Cleared Apr 13, 1998
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
K980147 · LPN
Automatic Liquid Packaging, Inc.
Ophthalmic · 88d
Cleared Apr 13, 1998
PREMIER 7000 CTL SPINE COIL
K980157 · MOS
Usa Instruments, Inc.
Radiology · 87d
Cleared Apr 13, 1998
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
K980169 · JAK
General Electric Co.
Radiology · 87d
Cleared Apr 13, 1998
HISPEED QX/I CT SCANNER SYSTEM
K980176 · JAK
General Electric Co.
Radiology · 83d
Cleared Apr 13, 1998
SHARPS PLUS 5 GALLON SHARPS CONTAINER
K980179 · FMI
Rotonics Mfg., Inc.
General Hospital · 83d
Cleared Apr 13, 1998
TELICAM
K980474 · EIA
Dental/Medical Diagnostic Systems, Inc.
Dental · 66d
Cleared Apr 13, 1998
FUJI I
K980695 · EMA
GC America, Inc.
Dental · 49d
Cleared Apr 10, 1998
VAPORIZATION ELECTRODES
K970961 · KNF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 389d
Cleared Apr 10, 1998
CV PERI-GUARD - CARDIOVASCULAR PATCH
K971726 · DXZ
Bio-Vascular, Inc.
Cardiovascular · 336d
Cleared Apr 10, 1998
CO2 PNEUMO-DISSECTOR
K972647 · HET
Cook Urological, Inc.
Obstetrics & Gynecology · 269d
Cleared Apr 10, 1998
FLOW RIDER FLOW DIRECTED MICRO CATHETER
K980104 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 88d
Cleared Apr 10, 1998
ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM
K980110 · GEH
Endocare, Inc.
General & Plastic Surgery · 88d
Cleared Apr 10, 1998
AMT DECOMPRESSION TUBES
K980145 · KGC
Applied Medical Technology, Inc.
Gastroenterology & Urology · 85d