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
83089–83112 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2000
RANDOX COMPLEMENT C4
K000468 · DBI
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Mar 27, 2000
RANDOX COMPLEMENT C3
K000469 · CZW
Randox Laboratories, Ltd.
Immunology · 45d
Cleared Mar 27, 2000
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
K000600 · KLI
Syva Co., Dade Behring, Inc.
Chemistry · 33d
Cleared Mar 27, 2000
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
K983214 · GXD
Rita Medical Systems
Neurology · 560d
Cleared Mar 27, 2000
MLC FIT
K991133 · IYE
Impac Medical Systems, Inc.
Radiology · 360d
Cleared Mar 27, 2000
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
K992303 · MUJ
Nucletron Corp.
Radiology · 263d
Cleared Mar 27, 2000
MCA-601, C-ARM MOBILE
K993896 · JAA
Medison Radiology Systems, Inc.
Radiology · 132d
Cleared Mar 27, 2000
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
K994389 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Mar 24, 2000
AESCULAP BONE WAX
K000021 · MTJ
Aesculap, Inc.
General & Plastic Surgery · 80d
Cleared Mar 24, 2000
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169 · EJR
Dentsply Intl.
Dental · 64d
Cleared Mar 24, 2000
HARDY DISK, PENICILLIN, 10 UNITS
K000302 · JTN
Hardy Diagnostics
Microbiology · 52d
Cleared Mar 24, 2000
BELLEGLASS HP TRANSLUCENT DENTIN
K000436 · EBF
Sybron Dental Specialties, Inc.
Dental · 43d
Cleared Mar 24, 2000
5F GUIDING CATHETER
K000598 · DQY
Guidant Corp.
Cardiovascular · 30d
Cleared Mar 24, 2000
THROMBOSTRATE CONTROL PLASMAS
K000679 · GGN
Pacific Hemostasis
Hematology · 24d
Cleared Mar 24, 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY...
K000821 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Mar 24, 2000
TFX MEDICAL INTRODUCER ASSEMBLY
K993191 · DYB
Tfx Medical, Inc.
Cardiovascular · 183d
Cleared Mar 24, 2000
RUSCH MANUAL RESUSCITATOR BAG
K993194 · BTM
Rusch, Inc.
Anesthesiology · 183d
Cleared Mar 24, 2000
ULTICARE DISPOSABLE SYRINGE
K994230 · FMF
Ultimed, Inc.
General Hospital · 99d
Cleared Mar 24, 2000
ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
K994370 · JWH
Ortho Development Corp.
Orthopedic · 88d
Cleared Mar 24, 2000
HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND...
K994373 · ITX
Atl Ultrasound, Inc.
Radiology · 88d
Cleared Mar 24, 2000
FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING
K994376 · DZE
Friadent GmbH
Dental · 88d
Cleared Mar 23, 2000
BELLEGLASS HP OPACEOUS DENTIN
K000269 · EBF
Sybron Dental Specialties, Inc.
Dental · 55d
Cleared Mar 23, 2000
REICHERT CT200 CONTACT TONOMETER
K000288 · HKY
Reichert Ophthalmic Instruments, Div....
Ophthalmic · 52d
Cleared Mar 23, 2000
PINNACLE ACETABULAR SYSTEM
K000306 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 51d