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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
94897–94920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1997
TETRIC CERAM
K964285 · EBF
Ivoclar North America, Inc.
Dental · 86d
Cleared Jan 22, 1997
LC-250 INFRARED LIGHT COAGULATOR
K964380 · HQB
Nk-Optik America
Ophthalmic · 79d
Cleared Jan 22, 1997
AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT
K964381 · KYI
Avanta Orthopaedics, Inc.
Orthopedic · 79d
Cleared Jan 22, 1997
HCL - 200 BIOCHEMISTRY ANALYZER
K964409 · JJF
Hcl Laboratory Systems, Inc.
Chemistry · 79d
Cleared Jan 22, 1997
APPLIED MEDICAL CLIP APPLIER
K964470 · FZP
Applied Medical Resources
General & Plastic Surgery · 76d
Cleared Jan 22, 1997
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR
K964525 · KLE
Dentsply Intl.
Dental · 71d
Cleared Jan 22, 1997
DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)
K964619 · EIA
Sds Dental, Inc.
Dental · 65d
Cleared Jan 22, 1997
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
K964754 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 56d
Cleared Jan 22, 1997
BASIC BIOPSY TRAY. DISPOSABLE, STERILE
K964921 · LRO
Trinity Laboratories, Inc.
General & Plastic Surgery · 44d
Cleared Jan 22, 1997
SEALITE SCIENCES, INC. AQUALITE LH
K964925 · CEP
Sealite Sciences, Inc.
Chemistry · 44d
Cleared Jan 22, 1997
A.C.T. I
K965149 · JSM
Remel Co.
Microbiology · 30d
Cleared Jan 22, 1997
A.C.T. IV
K965150 · JSM
Remel Co.
Microbiology · 30d
Cleared Jan 22, 1997
A.C.T. III
K965151 · JSM
Remel Co.
Microbiology · 30d
Cleared Jan 22, 1997
A.C.T. II
K965152 · JSM
Remel Co.
Microbiology · 30d
Cleared Jan 21, 1997
CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT
K954214 · OXP
Vysis
Pathology · 502d
Cleared Jan 21, 1997
IMMUNOCARD H. PYLORI
K961508 · LYR
Meridian Diagnostics, Inc.
Microbiology · 277d
Cleared Jan 21, 1997
NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM
K962796 · IYN
Medasonics, Inc.
Radiology · 187d
Cleared Jan 21, 1997
GLUCOMETER DEX DIABETES CARE SYSTEM
K963500 · CGA
Bayer Corp.
Chemistry · 140d
Cleared Jan 21, 1997
AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
K964574 · JHI
Athena Medical Corp.
Chemistry · 68d
Cleared Jan 21, 1997
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-II
K964639 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 63d
Cleared Jan 21, 1997
ELECSYS PROLACTIN ASSAY
K964748 · CFT
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Jan 21, 1997
SAS ONE-STEP PREGNANCY
K964995 · JHI
Sa Scientific, Inc.
Chemistry · 36d
Cleared Jan 17, 1997
ORTHODOC PREOPERATIVE PLANNER MODEL 500
K960685 · HWT
Integrated Surgical Systems, Inc.
Orthopedic · 332d
Cleared Jan 17, 1997
SIRIUS 10, 10L, 40, 40L
K961275 · EFB
Micro-Mega Societe Anonyme
Dental · 289d