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
103417–103440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 11, 1995
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
K950570 · JLS
Baxter Diagnostics, Inc.
Chemistry · 67d
Cleared Apr 11, 1995
MOBIL C-ARM, REGURBISHED, VARIOUS MODELS
K950971 · JAA
Pro-Tronics, Inc.
Radiology · 49d
Cleared Apr 11, 1995
OTI MODEL TLS-60
K951437 · HPC
Oti Medical, LLC
Ophthalmic · 15d
Cleared Apr 10, 1995
SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
K933177 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 649d
Cleared Apr 10, 1995
ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)
K940772 · LNH
Fonar Corp.
Radiology · 412d
Cleared Apr 10, 1995
STATLOCK-IPIDURAL
K943038 · FPA
Venetec, Inc.
General Hospital · 287d
Cleared Apr 10, 1995
CAPSET CALCIUM SULFATE BONE GRAFT PLASTER
K943186 · LYC
Lifecore Biomedical, Inc.
Dental · 279d
Cleared Apr 10, 1995
1085 ULTIMATE E PLETHYSMOGRAPH
K943259 · CCM
Medical Graphics Corp.
Anesthesiology · 278d
Cleared Apr 10, 1995
STERILE PHYSIOLOGICAL SALINE/STERILE WATER
K943661 · JOL
Medcare Custom Packaging, Inc.
General Hospital · 256d
Cleared Apr 10, 1995
LOW VOLUME MULTIPORT
K943770 · FPA
B. Braun of America, Inc.
General Hospital · 251d
Cleared Apr 10, 1995
IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS
K943983 · KXT
Instrumentation Laboratory CO
Toxicology · 307d
Cleared Apr 10, 1995
THE FLEX-SET SUBCUTANEOUS INFUSION SET
K944302 · FOZ
Cathco, Inc.
General Hospital · 216d
Cleared Apr 10, 1995
SC 6000/ SC 6000P/ R50
K944350 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 216d
Cleared Apr 10, 1995
THE HEART PROTECTOR
K944481 · NXB
Garan Scientific, Inc.
General Hospital · 209d
Cleared Apr 10, 1995
OLYMPUS ULTRASONIC PROBES
K944610 · ITX
Olympus America, Inc.
Radiology · 203d
Cleared Apr 10, 1995
CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC,...
K944763 · LYU
Wells Lamont Corp.
General Hospital · 195d
Cleared Apr 10, 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K944836 · MEH
Osteonics Corp.
Orthopedic · 192d
Cleared Apr 10, 1995
LOW TEMPERATURE CAUTERY FINE TIP, ADJUSTABLE, REPLACEABLE TIP
K945761 · HQP
Aaron Medical Industries
Ophthalmic · 152d
Cleared Apr 10, 1995
P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR
K945793 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 136d
Cleared Apr 10, 1995
RUNNING SUNGLASSES
K945808 · HQY
Million HU Corp.
Ophthalmic · 133d
Cleared Apr 10, 1995
SECURE SAFETY INSERT
K945825 · FMI
Syncor Intl. Corp.
General Hospital · 132d
Cleared Apr 10, 1995
OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES
K946234 · MEH
Osteonics Corp.
Orthopedic · 109d
Cleared Apr 10, 1995
HUMAN C-5 RADIAL IMMUNODIFFUSION KIT
K950102 · DAY
Kent Laboratories, Inc.
Immunology · 89d
Cleared Apr 10, 1995
LUHR(R) TITANIUM ALLOY BURR HOLE COVERS
K950105 · HRS
Howmedica Corp.
Orthopedic · 89d