FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90193–90216 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1998
AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE
K980305 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 79d
Cleared Apr 16, 1998
MICROSTREAM FILLERLINE OR/EMS
K980324 · CCK
Oridion Medical , Ltd.
Anesthesiology · 78d
Cleared Apr 16, 1998
MICROSTREAM NASAL CANNULA FILTERLINE
K980325 · CCK
Oridion Medical , Ltd.
Anesthesiology · 78d
Cleared Apr 16, 1998
MICROSTREAM FILTERLINE ICU
K980327 · CCK
Oridion Medical , Ltd.
Anesthesiology · 78d
Cleared Apr 16, 1998
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
K980356 · HHT
Canadian Medical Brush, Inc.
Obstetrics & Gynecology · 77d
Cleared Apr 16, 1998
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358 · KWP
Synthes (Usa)
Orthopedic · 77d
Cleared Apr 16, 1998
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
K980363 · LBB
Orofacial Dynamics
Neurology · 77d
Cleared Apr 16, 1998
GLADRAGS COTTON MENSTRUAL PAD
K980395 · HHD
Keepers!, Inc.
Obstetrics & Gynecology · 73d
Cleared Apr 16, 1998
PRESS-FIT STEM
K980473 · LZO
Encore Orthopedics, Inc.
Orthopedic · 69d
Cleared Apr 16, 1998
ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
K980736 · JHI
Acon Laboratories Co.
Chemistry · 50d
Cleared Apr 16, 1998
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
K980982 · GGN
Avocet Medical, Inc.
Hematology · 30d
Cleared Apr 16, 1998
COAMATIC FACTOR VIII
K981038 · GGP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Apr 16, 1998
STRATUS CS CKMB CALPAK
K981097 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 16, 1998
STRATUS CS TROP CALPAK
K981100 · JIT
Dade Behring, Inc.
Chemistry · 21d
Cleared Apr 16, 1998
UREA NITROGEN (BUN) LIQUID REAGENT
K981106 · CDQ
Teco Diagnostics
Chemistry · 21d
Cleared Apr 16, 1998
AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
K981165 · JHI
Germaine Laboratories, Inc.
Chemistry · 16d
Cleared Apr 15, 1998
MACRALP(A) ENZYME IMMUNOASSAY KIT
K971157 · JHO
Strategic Diagnostics, Inc.
Chemistry · 383d
Cleared Apr 15, 1998
BARD BTA TRAK TEST
K971402 · MMW
Bard Diagnostic Sciences,Inc.
Immunology · 365d
Cleared Apr 15, 1998
IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100
K973562 · IYN
Imex Medical Systems, Inc.
Radiology · 208d
Cleared Apr 15, 1998
KSEA N2O ENDOFLATOR
K980134 · HIF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 15, 1998
UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
K980525 · KWX
Marukin Shoyu Co., Ltd.
Chemistry · 63d
Cleared Apr 15, 1998
ND: YAG ACCESSORY FOR PHOTODERM SYSTEM
K980537 · GEX
Esc Medical Systems , Ltd.
General & Plastic Surgery · 63d
Cleared Apr 15, 1998
NTECH ARTHROSCOPE
K980599 · GCJ
N-Tech Endoscopy, Inc.
General & Plastic Surgery · 57d
Cleared Apr 15, 1998
NONWOVEN PAD
K980720 · KMF
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 50d