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
94705–94728 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1997
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
K964655 · JDI
Howmedica Corp.
Orthopedic · 78d
Cleared Feb 06, 1997
ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K964786 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 69d
Cleared Feb 06, 1997
ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES
K965007 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 52d
Cleared Feb 06, 1997
GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS...
K965038 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 51d
Cleared Feb 06, 1997
STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
K965169 · JJT
Specialized Assays, Inc.
Chemistry · 44d
Cleared Feb 06, 1997
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
K970009 · JTO
Microbiologics, Inc.
Microbiology · 35d
Cleared Feb 06, 1997
HCG CONTROLS
K970176 · JJX
International Newtech Development, Inc.
Chemistry · 20d
Cleared Feb 05, 1997
SUGITA AVM MICROCLIP
K960037 · HCH
Mizuho America, Inc.
Neurology · 399d
Cleared Feb 05, 1997
PLANNED SOPHIED CLASSIC
K962105 · IZH
Planmed OY
Radiology · 250d
Cleared Feb 05, 1997
DENTINSENSE
K964735 · KLE
Centrix, Inc.
Dental · 72d
Cleared Feb 05, 1997
AT 62 EEG (A.K.A THE A
K965006 · HCC
Stoelting Co.
Neurology · 51d
Cleared Feb 04, 1997
SAFE MICRO
K953976 · DTZ
Polystan A/S
Cardiovascular · 531d
Cleared Feb 04, 1997
ACCESS CHLAMYDIA ASSAY
K960850 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 340d
Cleared Feb 04, 1997
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024 · KTN
Princeton BioMeditech Corp.
Immunology · 327d
Cleared Feb 04, 1997
RAPID GRAM-POSITIVE ID SYSTEM
K961730 · LQL
Becton Dickinson Microbiology Systems
Microbiology · 277d
Cleared Feb 04, 1997
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
K961968 · LQL
Bd Becton Dickinson Vacutainer...
Microbiology · 260d
Cleared Feb 04, 1997
MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP...
K962653 · FAS
Microgyn Corp.
Gastroenterology & Urology · 211d
Cleared Feb 04, 1997
9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM
K963104 · DSP
Arrow Intl., Inc.
Cardiovascular · 179d
Cleared Feb 04, 1997
HERPES GROUP IGG ELISA TEST SYSTEM
K963645 · LGC
Armkel, LLC
Microbiology · 145d
Cleared Feb 04, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673 · KLT
Beckman Instruments, Inc.
Chemistry · 144d
Cleared Feb 04, 1997
PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS
K964245 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 103d
Cleared Feb 04, 1997
MIRACLE - EAR (ITE/ITC/CIC)
K964419 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 126d
Cleared Feb 04, 1997
PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM
K964485 · IYE
Eliav , Ltd.
Radiology · 88d
Cleared Feb 04, 1997
SLEEPWIZARD
K964494 · MNR
Nellcor Puritan Bennett, Inc.
Anesthesiology · 88d