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
125113–125136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1990
NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN
K902844 · EJF
Progressive Dental Supply
Dental · 69d
Cleared Sep 05, 1990
PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE
K903140 · BYJ
Puritan Bennett Corp.
Anesthesiology · 50d
Cleared Sep 05, 1990
OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS
K903214 · EJF
Medical Fittings, Inc.
Dental · 44d
Cleared Sep 05, 1990
ESCORT ITC
K903295 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 42d
Cleared Sep 05, 1990
FLOSSIE TOOTHFLOSS
K903712 · JES
Flossie, Inc.
Dental · 22d
Cleared Sep 05, 1990
COMFIT, PATIENT EXAMINATION GLOVES
K903746 · FMC
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 23d
Cleared Sep 05, 1990
STERILE PATIENT EXAMINATION GLOVES
K903756 · LYY
Tillotson Rubber Co., Inc.
General Hospital · 23d
Cleared Sep 05, 1990
AVI MODEL 270CM INFUSION PUMP
K903782 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
AVI MICRO 275CM INFUSION PUMP
K903783 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
AVI MODEL 400CM INFUSION PUMP
K903785 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
AVI MICRO 845 DUAL CHANNEL INFUSION PUMP
K903786 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
AVI MODEL 470CM INFUSION PUMP
K903787 · FRN
3M Avi, Inc.
General Hospital · 16d
Cleared Sep 05, 1990
MODEL RD-1200 RUBY LASER SYSTEM
K903849 · GEX
Charles L. Rose and Co., Inc.
General & Plastic Surgery · 15d
Cleared Sep 05, 1990
QUANTA LITE TM DSDNA
K903898 · LLL
Inova Diagnostics, Inc.
Immunology · 14d
Cleared Sep 05, 1990
SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET
K903969 · GAD
Karlin Technology, Inc.
General & Plastic Surgery · 8d
Cleared Sep 05, 1990
GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-DISTR SYST
K904002 · CAW
Pacific Consolidated Industries
Anesthesiology · 7d
Cleared Sep 04, 1990
MEDI, CURI EXAM GLOVES
K893060 · LYY
Golden Charter , Ltd.
General Hospital · 509d
Cleared Sep 04, 1990
ZEROWET SPLASHIELD
K900208 · KYZ
Zerowet Splashield
General Hospital · 230d
Cleared Sep 04, 1990
TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)
K900331 · BZG
Ghg Medizin-Elektronik AG
Anesthesiology · 224d
Cleared Sep 04, 1990
SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI
K900472 · HBN
Skytron, Div. the Kmw Group, Inc.
Neurology · 216d
Cleared Sep 04, 1990
MAINZ HEAD FIXATION BY PERNECZKY
K901393 · HBL
Zeppelin GmbH
Neurology · 162d
Cleared Sep 04, 1990
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
K901657 · DXK
Hitachi Medical Corp. of America
Cardiovascular · 147d
Cleared Sep 04, 1990
ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND
K901658 · DXK
Hitachi Medical Corp. of America
Cardiovascular · 147d
Cleared Sep 04, 1990
PEEP VALVE
K902062 · BYE
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 119d