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
95401–95424 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 1997
ACS HI-TORQUE IRON MAN GUIDE WIRE
K963702 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 128d
Cleared Jan 22, 1997
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
K963739 · HWC
Howmedica Leibinger, Inc.
Orthopedic · 127d
Cleared Jan 22, 1997
NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
K963937 · HWC
Northwest Precision Technologies
Orthopedic · 113d
Cleared Jan 22, 1997
CALCIUM HYDROXIDE MEDICAMENT
K964191 · EJK
Sybron Dental Specialties, Inc.
Dental · 93d
Cleared Jan 22, 1997
BIAFINE WOUND DRESSING EMULSION
K964240 · MGQ
Medix Pharmaceuticals Americas, Inc.
General & Plastic Surgery · 90d
Cleared Jan 22, 1997
NOVABED PATIENT TRANSFER SYSTEM
K964246 · FNL
Nova Technology Corp.
General Hospital · 90d
Cleared Jan 22, 1997
HEARTPORT ENDOCORONARY SINUS CATHETR
K964248 · DWF
Heartport, Inc.
Cardiovascular · 90d
Cleared Jan 22, 1997
SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
K964279 · KXO
Graphic Controls Corp.
Obstetrics & Gynecology · 86d
Cleared Jan 22, 1997
AUTOPRIME
K964283 · FPB
Arbor Technologies, Inc.
General Hospital · 86d
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