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
122473–122496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 1991
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
K904752 · JIR
Boehringer Mannheim Corp.
Chemistry · 175d
Cleared Apr 12, 1991
ADVANCE 418(TM)
K904984 · LIT
Peripheral Systems Group
Cardiovascular · 161d
Cleared Apr 12, 1991
ELECTRODE EXTENDER
K905060 · JOS
Megadyne Medical Products, Inc.
General & Plastic Surgery · 155d
Cleared Apr 12, 1991
DEFIBRILLATOR LEAD ADAPTER
K905065 · LDD
Spacelabs, Inc.
Cardiovascular · 156d
Cleared Apr 12, 1991
INCARE PINSITE DRESSING
K905206 · KOZ
Hollister, Inc.
General & Plastic Surgery · 143d
Cleared Apr 12, 1991
MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002
K905372 · HCC
Bio-Feedback Systems, Inc.
Neurology · 134d
Cleared Apr 12, 1991
ACCENT DG BALLOON URETERAL DILATOR SET
K905375 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 133d
Cleared Apr 12, 1991
ILC FORCEPS PADS
K905583 · HDA
Inman Liebelt Corp.
Obstetrics & Gynecology · 121d
Cleared Apr 12, 1991
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
K905643 · GHH
Agen Biomedical , Ltd.
Hematology · 116d
Cleared Apr 12, 1991
H-TRON V 100 INSULIN INFUSION PUMP
K905693 · LZG
Disetronic Medical Systems
General Hospital · 114d
Cleared Apr 12, 1991
ANTI-FOG DISPOSABLE IV INDUCTION COVER
K910104 · EYF
Central Plastic, Inc.
General & Plastic Surgery · 99d
Cleared Apr 12, 1991
LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST
K910233 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 84d
Cleared Apr 12, 1991
DANAM DATACELL-18
K910283 · GKZ
Danam Electronics
Hematology · 79d
Cleared Apr 12, 1991
CARDIOLAB AMPLIFIER MODULE (CAM)
K910307 · DRR
Prucka Engineering, Inc.
Cardiovascular · 78d
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