FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127105–127128 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1990
OXIMAX 700
K900866 · DQA
Pace Tech, Inc.
Anesthesiology · 40d
Cleared Apr 04, 1990
ALTERNATING PRESSURE PUMP AND PAD SYSTEM
K900871 · FNM
Three Bears Intl.
General Hospital · 39d
Cleared Apr 04, 1990
ADLER DISPOSABLE BIPOLAR CORD
K900913 · HQO
Adler Instrument Co.
Ophthalmic · 36d
Cleared Apr 04, 1990
DIACAM GAMMA CAMERA SYSTEM
K901019 · KPS
Siemens Gammasonics, Inc.
Radiology · 29d
Cleared Apr 04, 1990
PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
K901032 · DPS
Accucore, Inc.
Cardiovascular · 29d
Cleared Apr 04, 1990
REDYPLATE DISPOSABLE LEG PLATE
K901152 · HGP
Medical Accessories, Inc.
Obstetrics & Gynecology · 22d
Cleared Apr 03, 1990
MXR-14 FILM PROCESSOR
K890486 · IXW
Cordell, Inc.
Radiology · 427d
Cleared Apr 03, 1990
STEADFAST DENTURE ADHESIVE CREAM
K895818 · KOT
Stiefel Research Institute, Inc.
Dental · 186d
Cleared Apr 03, 1990
LDW SPIROMETRY SYSTEM
K896300 · BZG
Lanpher Diagnostic Workstations, Inc.
Anesthesiology · 155d
Cleared Apr 03, 1990
EXEC-WASH SOLID PHASE WASHING SYSTEM
K896631 · JQW
Source Scientific Systems, Inc.
Chemistry · 132d
Cleared Apr 03, 1990
SIGMA PROCEDURE NO. 735
K897147 · KHP
Sigma Diagnostics, Inc.
Chemistry · 98d
Cleared Apr 03, 1990
NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
K900010 · JFT
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 91d
Cleared Apr 03, 1990
ARISTEE (RESIN, CROWN AND BRIDGES)
K900068 · EBG
Prometex, Inc.
Dental · 89d
Cleared Apr 03, 1990
FG DIAMOND BURRS
K900089 · DZP
Kab Gloves Unltd.
Dental · 88d
Cleared Apr 03, 1990
SNAP MYCOBACTERIA AVIUM COMPLEX
K900202 · LQF
Syngene, Inc.
Microbiology · 77d
Cleared Apr 03, 1990
AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
K900204 · FRN
3M Company
General Hospital · 77d
Cleared Apr 03, 1990
COULTER AMYLASE REAGENT
K900230 · JFJ
Coulter Corp.
Chemistry · 76d
Cleared Apr 03, 1990
COULTER CALCIUM REAGENT
K900231 · CJY
Coulter Corp.
Chemistry · 76d
Cleared Apr 03, 1990
SNAP M. TUBERCULOSIS COMPLEX
K900292 · LQF
Syngene, Inc.
Microbiology · 71d
Cleared Apr 03, 1990
PREBYPASS FILTER, CAT. NO. FPB-5
K900672 · KRJ
American Omni Medical, Inc.
Cardiovascular · 49d
Cleared Apr 03, 1990
SERIAL FLOW
K900673 · BZG
Spirometrics, Inc.
Anesthesiology · 49d
Cleared Apr 03, 1990
CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
K900676 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 50d
Cleared Apr 03, 1990
SMU 611 UNIVERSALMONITOR
K900700 · DPS
Ppg Industries, Inc.
Cardiovascular · 50d
Cleared Apr 03, 1990
NOVAPATH MICROPLATE READER
K900776 · JJQ
Bio-Rad
Chemistry · 42d