Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

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175,820 results
144241–144264 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1986
TM-3600 A NEURODIAGNOSTIC SYSTEM
K860903 · GWF
Tracor Northern, Inc.
Neurology · 87d
Cleared Jun 05, 1986
PARAGON 420, CARDIAC MONITOR
K861067 · DPS
Life Sensing Instrument Company, Inc.
Cardiovascular · 77d
Cleared Jun 05, 1986
COLLINS PNEUMOTACH PFT SYSTEM
K861227 · BZG
Warren E. Collins, Inc.
Anesthesiology · 65d
Cleared Jun 05, 1986
RX-33S INTRA MINI CANAL MODULE
K861532 · ESD
Rexton, Inc.
Ear, Nose, Throat · 42d
Cleared Jun 05, 1986
CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT
K861555 · BZD
Respiratory Care, Inc.
Anesthesiology · 41d
Cleared Jun 05, 1986
CREATINE PHROSPHOKINASE (CK) PROCEDURE
K861665 · CGS
Data Medical Associates, Inc.
Chemistry · 36d
Cleared Jun 05, 1986
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
K861893 · JXL
Hi Chem, Inc.
Chemistry · 20d
Cleared Jun 05, 1986
SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER
K862042 · KFZ
Associated Mills, Inc.
Anesthesiology · 8d
Cleared Jun 05, 1986
TITERTEK MICROPLATE WASHER S-12
K862066 · JTC
Flow Laboratories, Inc.
Microbiology · 6d
Cleared Jun 05, 1986
E. T. TAPE ENDOTRACHEAL TUBE HOLDER
K862084 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 3d
Cleared Jun 04, 1986
TE-25 COAGURO METER
K854686 · JBP
Future Impex Corp.
Hematology · 196d
Cleared Jun 04, 1986
ERMA HB-METER MODEL 303N
K854687 · KHG
Future Impex Corp.
Hematology · 196d
Cleared Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
K860609 · FPA
Ipax, Inc.
General Hospital · 105d
Cleared Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
K861182 · FPA
Ipax, Inc.
General Hospital · 65d
Cleared Jun 04, 1986
APLICARE SKIN PROTECTANT SWABSTICK
K861558 · NEC
Aplicare, Inc.
General & Plastic Surgery · 40d
Cleared Jun 04, 1986
RUBALEX (REVISED VERSION)
K861881 · LQN
Orion Corp.
Microbiology · 27d
Cleared Jun 04, 1986
STERILE TOWEL W/ANTIMICROBIAL AGENT
K861969 · KKX
Deroyal Industries, Inc.
General Hospital · 15d
Cleared Jun 04, 1986
PACH-PEN SURGICAL DRAPE
K862016 · KKX
Oculab, Inc.
General Hospital · 7d
Cleared Jun 03, 1986
DIRECTATEX STREP A
K861575 · GTY
Pacific Biotech, Inc.
Microbiology · 36d
Cleared Jun 03, 1986
HIPPURATE HYDROLYSIS TEST
K861888 · JTO
Pro-Lab, Inc.
Microbiology · 18d
Cleared Jun 03, 1986
D'ALA RAPID TEST
K861889 · JTO
Pro-Lab, Inc.
Microbiology · 18d
Cleared Jun 03, 1986
100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2
K861890 · PPM
Richard-Allan Medical Ind., Inc.
Pathology · 18d
Cleared Jun 02, 1986
CARDIOCAP MONITOR
K853953 · DRT
Instrumentarium Corp.
Cardiovascular · 250d
Cleared Jun 02, 1986
THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT
K854856 · DWJ
Thermorite, Inc.
Cardiovascular · 179d