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
121897–121920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1991
OHMEDA - LOW FLOW FLOWMETER
K910316 · CAX
Ohmeda Medical
Anesthesiology · 78d
Cleared Apr 12, 1991
CHALLENGE (TM) LIQ THERA DRUG CONTROLS
K910333 · DIF
Medical Analysis Systems, Inc.
Chemistry · 77d
Cleared Apr 12, 1991
SYNCHRON C-REACTIVE PROTEIN REAGENT
K910535 · DCN
Beckman Instruments, Inc.
Immunology · 63d
Cleared Apr 12, 1991
VISI-STREP
K910537 · LQL
Kev Connecticut Diagnostics, Inc.
Microbiology · 63d
Cleared Apr 12, 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)
K910547 · LZO
Turnkey Intergration USA, Inc.
Orthopedic · 64d
Cleared Apr 12, 1991
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
K910633 · CGA
Yellow Springs Instrument Co., Inc.
Chemistry · 58d
Cleared Apr 12, 1991
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
K910639 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Apr 12, 1991
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
K910640 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Apr 12, 1991
FLEXMEDICS MALLEABLE CANNULA
K910674 · HRX
Flexmedics
Orthopedic · 56d
Cleared Apr 12, 1991
CANDELA MINI-UB ENDOSCOPE
K910732 · ODF
Candela Laser Corp.
Gastroenterology & Urology · 50d
Cleared Apr 12, 1991
PROPAQ 102, 104 AND 106
K910772 · DXN
Protocol Systems, Inc.
Cardiovascular · 49d
Cleared Apr 12, 1991
ALLDRESS MULTI LAYERED WOUND DRESSING
K910857 · NAB
Scott Health Care
General & Plastic Surgery · 43d
Cleared Apr 12, 1991
EBV IGG ELISA TEST
K910872 · MCD
Gull Laboratories, Inc.
Microbiology · 42d
Cleared Apr 12, 1991
LANEX EXAM GLOVES
K910977 · LYY
Multi M Intl., Inc.
General Hospital · 36d
Cleared Apr 12, 1991
LH IRMA IMMUNOMAG
K911050 · CEP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 35d
Cleared Apr 12, 1991
FIXATION PIN
K911452 · HTY
Simpex, Inc.
Orthopedic · 9d
Cleared Apr 12, 1991
FIXATION WIRE
K911505 · HTY
Simpex, Inc.
Orthopedic · 8d
Cleared Apr 10, 1991
MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER
K900557 · CCQ
Monaghan Medical Corp.
Anesthesiology · 427d
Cleared Apr 10, 1991
RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
K903020 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 273d
Cleared Apr 10, 1991
MENTOR EEG SYSTEM
K904763 · GWQ
Oxford Medilog, Inc.
Neurology · 170d
Cleared Apr 10, 1991
BACTERIA FILTER
K904830 · CAH
Vital Signs, Inc.
General Hospital · 167d
Cleared Apr 10, 1991
HBO CABLE ASSEMBLY, RADIOMETER TC-02
K905225 · LKD
Sechrist
Radiology · 141d
Cleared Apr 10, 1991
MINIATURE TEMPERATURE TRAINER MODEL DT-002
K905373 · HCC
Bio-Feedback Systems, Inc.
Neurology · 132d
Cleared Apr 10, 1991
SMT-50X
K905634 · LNH
Shimadzu Medical Systems
Radiology · 114d