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
99193–99216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1996
XENON OPTION TO PRISM 3000
K955484 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 119d
Cleared Mar 29, 1996
OLYMPUS SD SERIES SNARES
K955650 · FDI
Olympus America, Inc.
Gastroenterology & Urology · 108d
Cleared Mar 29, 1996
MULTI-CENTRIFUGE
K955795 · GKG
Novonx, Inc.
Hematology · 98d
Cleared Mar 29, 1996
AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM
K955811 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 94d
Cleared Mar 29, 1996
HICHEM BUN/UREA REAGENT KIT
K960115 · CDQ
Elan Pharma, Inc.
Chemistry · 78d
Cleared Mar 29, 1996
P.E.G. PATIENT CARE KIT
K960177 · KNT
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 73d
Cleared Mar 29, 1996
VACUTAINER BRAND PLUS SERUM & SST TUBES
K960250 · JKA
Becton Dickinson Vacutainer Systems
Chemistry · 73d
Cleared Mar 29, 1996
ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY
K960274 · JIR
Orgentec
Chemistry · 70d
Cleared Mar 29, 1996
SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)
K960801 · DQO
North American Instrument Corp.
Cardiovascular · 31d
Cleared Mar 29, 1996
HELIODENT DS
K960819 · EAP
Pelton & Crane Co.
Radiology · 29d
Cleared Mar 29, 1996
ACCESS FREE T3 ASSAY
K960913 · CDP
Bio-Rad Laboratories, Inc.
Chemistry · 23d
Cleared Mar 28, 1996
SOLOPICC 24 (60CM) 20GA CATHETER
K954428 · FOZ
Douglas Medical Products Corp.
General Hospital · 188d
Cleared Mar 28, 1996
W-55 (METHAFILON A) CONTACT LENS
K954524 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 181d
Cleared Mar 28, 1996
CONFI-BOND
K955328 · KLE
Confi-Dental Products Co.
Dental · 129d
Cleared Mar 28, 1996
RESILIENCE M5 PROTECTION PLUS
K955329 · DYH
Confi-Dental Products Co.
Dental · 129d
Cleared Mar 28, 1996
TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS
K955366 · HQD
Rand Scientific Corp.
Ophthalmic · 127d
Cleared Mar 28, 1996
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K955831 · BSY
Sherwood Medical Co.
Anesthesiology · 93d
Cleared Mar 28, 1996
STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX
K955901 · HQC
Storz Instrument Co.
Ophthalmic · 90d
Cleared Mar 28, 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
K955909 · GKZ
Dako Corp.
Hematology · 90d
Cleared Mar 28, 1996
BIOHORIZONS DENTAL IMPLANT SYSTEM
K960026 · DZE
BioHorizons Implant Systems, Inc.
Dental · 86d
Cleared Mar 28, 1996
NIPRO SAFELET CATH
K960051 · FOZ
Nissho Corp.
General Hospital · 84d
Cleared Mar 28, 1996
ACTIVE CROSSLAPS ELISA
K960171 · JMM
Diagnostic Systems Laboratories, Inc.
Chemistry · 72d
Cleared Mar 28, 1996
AMSINO CLINICAL THERMOMETER
K960185 · FLK
Amsia Intl., Inc.
General Hospital · 72d
Cleared Mar 28, 1996
CPR BASIC SET-UP TRAY
K960208 · FRG
Custom Pack Reliability
General Hospital · 72d