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
121897–121920 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1991
SPENCIO SKIN GUARD KIT
K910927 · KMF
Spenco Medical Corp.
General & Plastic Surgery · 90d
Cleared Jun 03, 1991
OLYMPUS ANGIOSCOPY IRRIGATION SHEATH
K910933 · DYB
Olympus Corp.
Cardiovascular · 89d
Cleared Jun 03, 1991
NEV-10 NEGATIVE PRESSURE VENTILATOR
K910947 · BYT
Lifecare Services, Inc.
Anesthesiology · 89d
Cleared Jun 03, 1991
INVOTEC MICROSCOPE DRAPE
K911040 · HMW
Invotec International, Inc.
General Hospital · 87d
Cleared Jun 03, 1991
CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT
K911053 · GCJ
Circon Video
General & Plastic Surgery · 87d
Cleared Jun 03, 1991
NORCATH VASCULAR ACCESS CATHETERS
K911067 · LJS
Norfolk Medical
General Hospital · 84d
Cleared Jun 03, 1991
IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS
K911163 · FWF
Imagyn Medical, Inc.
General & Plastic Surgery · 80d
Cleared Jun 03, 1991
SYNERMED UREA NITROGEN REAGENT KIT
K911248 · CDQ
Synermed, Inc.
Chemistry · 74d
Cleared Jun 03, 1991
CROSSFIRE LASER ASSISTED ASPIRATION CANNULA
K911408 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 63d
Cleared Jun 03, 1991
TRUMPET VALVE
K911415 · FMG
B. Braun of America, Inc.
General Hospital · 63d
Cleared Jun 03, 1991
ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD
K911725 · LCM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 47d
Cleared Jun 03, 1991
RATEMINDER(TM) V INFUSION PUMP, MODIFICATION
K911769 · FRN
Critikon Company, LLC
General Hospital · 45d
Cleared Jun 03, 1991
INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER
K911840 · DYG
Intec Medical, Inc.
Cardiovascular · 39d
Cleared Jun 03, 1991
DASH MEDICAL GLOVES
K912038 · LYY
Safehealth Labs
General Hospital · 26d
Cleared May 31, 1991
VIBROMETRY SYSTEM
K901881 · LNN
Bruel & Kjaer Instruments, Inc.
Gastroenterology & Urology · 400d
Cleared May 31, 1991
RHEUMAGEN RF T-CONTROL
K904310 · DHR
Biokit USA, Inc.
Immunology · 254d
Cleared May 31, 1991
VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.
K904813 · EBF
Alpha-Dent
Dental · 218d
Cleared May 31, 1991
IV EXTENSION SETS WITH .22 MICRON FILTER
K905374 · FPA
Marquette Medical, Inc.
General Hospital · 183d
Cleared May 31, 1991
MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING
K905464 · CBT
Angiosystems, Inc.
Anesthesiology · 177d
Cleared May 31, 1991
VOLUMETRIC INFUSION PUMP
K910024 · FRN
Baxter Healthcare Corp
General Hospital · 148d
Cleared May 31, 1991
SPLINTER TWEEZERS
K910570 · FSM
Solan Scissors Sales
General & Plastic Surgery · 109d
Cleared May 31, 1991
ENDOPATH SURGICAL INSTRUMENTS
K910831 · GEI
Symbiosis Corp.
General & Plastic Surgery · 93d
Cleared May 31, 1991
INFUSION PUMP
K910844 · FRN
Technology Transfer Intl., Inc.
General Hospital · 93d
Cleared May 31, 1991
T600 TREADMILL
K910867 · IOL
Siemens Burdick, Inc.
Physical Medicine · 91d