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
165553–165576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1980
ANESTHESIA GAS MACHINE
K802116 · BZC
Puritan Bennett Corp.
Anesthesiology · 29d
Cleared Oct 03, 1980
BEAR 2 ADULT VOL. VENTILATOR
K802118 · CBK
Bourns Medical Systems, Inc.
Anesthesiology · 29d
Cleared Oct 03, 1980
CM-700A AUTO-INFLATE CONTROL MODULE
K802203 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 22d
Cleared Oct 03, 1980
CT-1600 DIGITAL PULSE RATE MONITOR
K802204 · DRT
Industrial & Biomedical Sensors Corp.
Cardiovascular · 22d
Cleared Oct 03, 1980
ECG/RESPIRATION STIMULATOR
K802205 · BZQ
Healthdyne, Inc.
Anesthesiology · 22d
Cleared Oct 03, 1980
CORROSION PROOF SNAP ECG CONNECT WIRES
K802236 · DSA
Custom Cardio Components
Cardiovascular · 18d
Cleared Oct 03, 1980
CORROSION PROOF DUAL PURPOSE ECG WIRES
K802237 · DSA
Custom Cardio Components
Cardiovascular · 18d
Cleared Oct 03, 1980
VESSEL RETRACTOR, #600732
K802244 · DXC
Bentley Laboratories, Inc.
Cardiovascular · 17d
Cleared Oct 03, 1980
HOT CYCLE, A CHEMICAL TYPE HOT PACK
K802252 · IMD
Signal West
Physical Medicine · 17d
Cleared Oct 03, 1980
PRESSURE GAUGE ACCESSORY KIT/DILATATION
K802261 · DWF
Stanco Medical, Inc.
Cardiovascular · 17d
Cleared Oct 03, 1980
PROTECTIVE BAR FOR THE MA-1VENTILATOR
K802270 · CBK
Eastern Anesthesia, Inc.
Anesthesiology · 16d
Cleared Oct 03, 1980
TELEMETRY TRANSMITTER, #TLT-3
K802273 · DRG
Bd Becton Dickinson Vacutainer...
Cardiovascular · 16d
Cleared Oct 03, 1980
SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC
K802281 · CCQ
Sherwood Medical Co.
Anesthesiology · 14d
Cleared Oct 03, 1980
OHIO THORACIC SUCTION REGULATOR
K802285 · KOP
Ohio Medical Products
Dental · 14d
Cleared Oct 03, 1980
MINGOGRAF EEG21
K802292 · GWQ
Siemens Corp.
Neurology · 14d
Cleared Oct 03, 1980
MINGOGRAF EEG10
K802296 · GWQ
Siemens Corp.
Neurology · 14d
Cleared Oct 03, 1980
PEDIATRIC OXYGEN OR AEROSOL MASKS,
K802323 · BYG
Airlife, Inc.
Anesthesiology · 10d
Cleared Oct 03, 1980
DISPOSABLE CONSTRAST DELIVERY SPIKE KIT
K802329 · FPA
Stanco Medical, Inc.
General Hospital · 10d
Cleared Sep 30, 1980
URINE COLLECTION CONTAINERS, #3600 &3610
K801786 · KOD
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 30, 1980
NU-VISION DISP. OPHTHALMIC DRESSING TRAY
K801822 · KYG
Summit Optics, Inc.
Ophthalmic · 61d
Cleared Sep 26, 1980
CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL
K792377 · DHX
Environmental Chemical Specialties
Immunology · 305d
Cleared Sep 26, 1980
BIFOCAL 2 8200 SERIES (A,B C,D)
K800379 · DXY
American Pacemaker Corp.
Cardiovascular · 217d
Cleared Sep 26, 1980
HEARTWATCH
K800519 · DRT
D. Jenkins
Cardiovascular · 204d
Cleared Sep 26, 1980
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH
K800857 · LCP
Helena Laboratories
Hematology · 164d