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
116065–116088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1992
ASTECH HOME PEAK FLOW METER
K915060 · BZH
Biotrine Corp.
Anesthesiology · 308d
Cleared Sep 11, 1992
MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
K915188 · DTB
Cook Pacemaker Corp.
Cardiovascular · 298d
Cleared Sep 11, 1992
SPLATTER SHIELD
K915676 · FMF
Chathamborough Research Group, Inc.
General Hospital · 267d
Cleared Sep 11, 1992
DISPOSABLE FORCEPS
K920296 · MDM
Falcon Instruments, Inc.
General & Plastic Surgery · 233d
Cleared Sep 11, 1992
DISPOSABLE SCISSORS
K920297 · MDM
Falcon Instruments, Inc.
General & Plastic Surgery · 233d
Cleared Sep 11, 1992
THE PEAK
K920390 · BZH
Multispiro, Inc.
Anesthesiology · 225d
Cleared Sep 11, 1992
MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE
K920469 · FLL
Respiratory Support Products, Inc.
General Hospital · 228d
Cleared Sep 11, 1992
PNEUMO-WEDGE
K921143 · FQO
Kansas Creative Devices, Inc.
General & Plastic Surgery · 184d
Cleared Sep 11, 1992
AEROSTAR
K921313 · CBN
Biosafety Systems, Inc.
Anesthesiology · 177d
Cleared Sep 11, 1992
REUSABLE DUAL DISC BAR ELECTRODES, VARIOUS MODELS
K921504 · JXE
Chalgren Enterprises, Inc.
Neurology · 164d
Cleared Sep 11, 1992
MED-TENS
K921813 · GZJ
Ems Dist.
Neurology · 149d
Cleared Sep 11, 1992
SCANMATE III
K921878 · IYP
Circadian, Inc.
Radiology · 144d
Cleared Sep 11, 1992
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900
K921963 · HIF
Sun Medical, Inc.
Obstetrics & Gynecology · 137d
Cleared Sep 11, 1992
WATERS(TM) LC MODULE I FOR CLINICAL USE
K922388 · LDM
Millipore Corp.
Toxicology · 114d
Cleared Sep 11, 1992
MOBILE ATHENA HF
K922454 · IZH
Fischer Imaging Corp.
Radiology · 108d
Cleared Sep 11, 1992
DU PONT COMPACT DAYLIGHT SYSTEM 2000
K922483 · KPX
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 107d
Cleared Sep 11, 1992
CONSENSUS(TM) BIPOLAR SYSTEM
K922560 · KWY
U.S. Medical Products, Inc.
Orthopedic · 105d
Cleared Sep 11, 1992
ROCHE ENTEROTUBE II
K922588 · JSS
Roche Diagnostic Systems, Inc.
Microbiology · 102d
Cleared Sep 11, 1992
PROSPECT GIARDIA CONTROLS
K922675 · MHI
Alexon, Inc.
Microbiology · 99d
Cleared Sep 11, 1992
TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT
K922814 · IZO
Bay Shore Medical Equipment Corp.
Radiology · 101d
Cleared Sep 11, 1992
DISPSABLE FORCEPS, HEMOSTATS, PROBES, NEEDLE GUIDE
K922874 · MDM
Supra Instruments, Inc.
General & Plastic Surgery · 88d
Cleared Sep 11, 1992
ISOPORE TAPE
K922959 · KGX
Lectec Corp.
General & Plastic Surgery · 85d
Cleared Sep 11, 1992
SCAN BAND
K923106 · JAK
Cook, Inc.
Radiology · 78d
Cleared Sep 11, 1992
TRIAD INLAY COMPOSITE
K923236 · EBF
Dentsply Intl.
Dental · 72d