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
122497–122520 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 10, 1991
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
K910107 · DTZ
Baxter Healthcare Corp
Cardiovascular · 90d
Cleared Apr 10, 1991
LOW VISION ENHANCEMENT SYSTEM (LVES)
K910124 · HPG
Triangle Investments
Ophthalmic · 89d
Cleared Apr 10, 1991
OPTICAL FRAME
K910179 · HQZ
Australian Optical Co., Inc.
Ophthalmic · 85d
Cleared Apr 10, 1991
OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
K910707 · HOZ
Jedmed Instrument Co.
Ophthalmic · 49d
Cleared Apr 09, 1991
OSCAR(TM) II CAPNOMETER & PULSE OXIMETER
K904843 · CBR
Dalton Instrument Corp.
Anesthesiology · 166d
Cleared Apr 09, 1991
HAEMODIALYSIS CONCENTRATE
K904946 · KPO
Bdh, Inc.
Gastroenterology & Urology · 159d
Cleared Apr 09, 1991
BARD(R) SYRINGE ASSIST IRRIGATION
K905102 · OCX
C.R. Bard, Inc.
Gastroenterology & Urology · 147d
Cleared Apr 09, 1991
FORMASURE TEST REAGENT
K905217 · LIF
Di-Chem, Inc.
Gastroenterology & Urology · 140d
Cleared Apr 09, 1991
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
K905288 · BYG
Med-Tek Innovations, Inc.
Anesthesiology · 134d
Cleared Apr 09, 1991
VARIOUS TYPES OF STETHOSCOPES
K905487 · LDE
Liaoning-Usa Corp.
Cardiovascular · 124d