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
137089–137112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1988
KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS
K874643 · HSD
Kirschner Medical Corp.
Orthopedic · 54d
Cleared Jan 06, 1988
MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER
K874930 · DTB
Intermedics, Inc.
Cardiovascular · 35d
Cleared Jan 05, 1988
EBV-EA TEST
K872617 · LSE
Gull Laboratories, Inc.
Microbiology · 183d
Cleared Jan 05, 1988
BETATRON IV SYSTEM
K872774 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 175d
Cleared Jan 05, 1988
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)
K873371 · CHQ
Bio-Rad
Chemistry · 137d
Cleared Jan 05, 1988
LUMICON
K873893 · JJQ
Hamilton Co.
Chemistry · 104d
Cleared Jan 05, 1988
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
K874033 · JHI
Diagnostic Products Corp.
Immunology · 95d
Cleared Jan 05, 1988
CELL COUNTING GRID GRATICULE
K874190 · IBJ
Portable Medical Laboratories, Inc.
Hematology · 83d
Cleared Jan 05, 1988
THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
K874207 · IBJ
Intl. Remote Imaging Systems
Pathology · 82d
Cleared Jan 05, 1988
MRI STRETCHER
K874332 · FPO
Atomic Products Corp.
General Hospital · 75d
Cleared Jan 05, 1988
PT PRO-CLOT
K874373 · JBR
Probe-Tek, Inc.
Hematology · 71d
Cleared Jan 05, 1988
REAGENT A AND REAGENT B
K874413 · JIX
Seradyn, Inc.
Chemistry · 69d
Cleared Jan 05, 1988
QBC SYSTEM HEMOGLOBIN
K874427 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 69d
Cleared Jan 05, 1988
FLUID SAMPLING PACK
K874436 · KSS
U.S. Mfg. & Management, Inc.
Hematology · 69d
Cleared Jan 05, 1988
BLOOD UREA NITROGEN
K874532 · CDW
Catachem, Inc.
Chemistry · 63d
Cleared Jan 05, 1988
PARAMAX URINE/CSF CALIBRATOR
K874587 · JIX
Baxter Healthcare Corp
Chemistry · 57d
Cleared Jan 05, 1988
REVISED LABELING FOR SYVA BARBITURATE ASSAYS
K874702 · DIS
Syva Co.
Toxicology · 50d
Cleared Jan 05, 1988
REFLOTRON (R) AMYLASE
K874704 · JFJ
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Jan 05, 1988
DC-TROL LEVEL 1 OR 2
K874772 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 47d
Cleared Jan 05, 1988
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM
K874810 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Jan 05, 1988
PROSPECT/GIARDIA
K874849 · KHW
Alexon Biomedical, Inc.
Microbiology · 41d
Cleared Jan 05, 1988
EMIT CONVENIENCE PACK: PHENYTOIN ASSAY
K874856 · DIP
Syva Co.
Toxicology · 41d
Cleared Jan 05, 1988
SAKURA DRS-60 AUTOMATIC SLIDE STAINER
K874897 · KPA
Sakura Finetek U.S.A., Inc.
Pathology · 35d
Cleared Jan 05, 1988
MUG-INDOLE DISC
K874933 · JTO
Scott Laboratories, Inc.
Microbiology · 32d