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

Filters: Cleared only ×
175,820 results
134065–134088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 25, 1988
REDY 2000
K882428 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 134d
Cleared Oct 25, 1988
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II
K882486 · JJY
Bio-Rad
Chemistry · 131d
Cleared Oct 25, 1988
STREPSLIDE
K882811 · GTY
Ncs Diagnostics, Inc.
Microbiology · 110d
Cleared Oct 25, 1988
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K883083 · GSA
Medical Diagnostic Technologies, Inc.
Microbiology · 96d
Cleared Oct 25, 1988
CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
K883104 · JMO
Technicon Instruments Corp.
Chemistry · 92d
Cleared Oct 25, 1988
MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION
K883173 · OCX
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 25, 1988
FDL ELISA FOR CHLAMYDIA
K883266 · LJC
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 83d
Cleared Oct 25, 1988
CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST
K883321 · JJE
Heraeus Kulzer, Inc.
Chemistry · 81d
Cleared Oct 25, 1988
PMD SYSTEM-20
K883390 · KMI
Datatek, Inc.
General Hospital · 77d
Cleared Oct 25, 1988
DENTA PLUS
K883403 · JER
Connoisseurs Products Corp.
Dental · 75d
Cleared Oct 25, 1988
ROCHE REAGENT FOR CALCIUM
K883453 · CJY
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Oct 25, 1988
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME
K883479 · CDP
Baxter Healthcare Corp
Chemistry · 70d
Cleared Oct 25, 1988
KRATZ NOVA SERT(TM)
K883489 · KYB
Coopervision-Cilco
Ophthalmic · 70d
Cleared Oct 25, 1988
OXALATE REAGENT
K883525 · LPW
Sigma Chemical Co.
Chemistry · 69d
Cleared Oct 25, 1988
CDT CYTOTOXI TEST
K883560 · LLH
Advanced Clinical Diagnostics
Microbiology · 67d
Cleared Oct 25, 1988
MODIFIED REUSABLE SITE FIBER OPTIC CABLE
K883605 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 63d
Cleared Oct 25, 1988
I-SPOSE EYE SHIELD
K883658 · FXX
Products For Medicine
General Hospital · 60d
Cleared Oct 25, 1988
RUBELLA IGM MICROASSAY
K883778 · LFX
Diamedix Corp.
Microbiology · 49d
Cleared Oct 25, 1988
FIBER OPTIC LARYNGOSCOPE
K883830 · CCW
Effner, Inc.
Anesthesiology · 46d
Cleared Oct 25, 1988
QLIA T UPTAKE ASSAY
K883971 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Oct 25, 1988
DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.
K883975 · HQE
Site Microsurgical Systems, Inc.
Ophthalmic · 35d
Cleared Oct 25, 1988
ADD-A-CATH
K884061 · KOB
Femcare , Ltd.
Gastroenterology & Urology · 29d
Cleared Oct 25, 1988
SNAP N' STAIN IODINE STAIN
K884069 · JTS
Scientific Device Laboratory, Inc.
Pathology · 28d
Cleared Oct 25, 1988
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)
K884208 · KZI
Oxoid U.S.A., Inc.
Microbiology · 19d