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
91633–91656 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1997
CHIN DISTRACTOR
K973484 · JEY
Howmedica, Inc.
Dental · 78d
Cleared Dec 02, 1997
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
K973611 · FCL
Spectrascience, Inc.
Gastroenterology & Urology · 71d
Cleared Dec 01, 1997
MEDI-DX 7000
K964622 · LLN
Neuro-Diagnostic Assoc.
Neurology · 378d
Cleared Dec 01, 1997
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964703 · MOI
Bayer Corp.
Immunology · 374d
Cleared Dec 01, 1997
TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
K971205 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 244d
Cleared Dec 01, 1997
QUANTA LITE CMV IGG ELISA
K971335 · LFZ
Inova Diagnostics, Inc.
Microbiology · 235d
Cleared Dec 01, 1997
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
K972064 · FRA
Biological Controls, Inc.
General Hospital · 181d
Cleared Dec 01, 1997
INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450
K972112 · GBW
Taut, Inc.
General & Plastic Surgery · 179d
Cleared Dec 01, 1997
MONOCOL/LEX-IM TEST
K972457 · KTN
Immunostics Inc.,
Immunology · 153d
Cleared Dec 01, 1997
INNOVASIVE DEVICES Y-KNOT SUTURE CLIP
K973313 · OCW
Innovasive Devices, Inc.
Gastroenterology & Urology · 89d
Cleared Dec 01, 1997
ACL CLIP-IN
K973323 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Dec 01, 1997
BIODERM FOAM WOUND DRESSING
K973429 · KMF
Bioderm, Inc.
General & Plastic Surgery · 82d
Cleared Dec 01, 1997
CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973479 · JTN
Oxoid , Ltd.
Microbiology · 77d
Cleared Dec 01, 1997
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
K973495 · ECI
Glenroe
Dental · 76d
Cleared Dec 01, 1997
THE AUTO SUTURE* MIBB** SYSTEM
K973496 · KNW
United States Surgical, A Division of...
Gastroenterology & Urology · 77d
Cleared Dec 01, 1997
ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
K973657 · MGP
Maersk Medical, Ltd.
General & Plastic Surgery · 67d
Cleared Dec 01, 1997
QUICKVUE ONE-STEP HCG-COMBO
K973841 · JHI
Quidel Corp.
Chemistry · 54d
Cleared Dec 01, 1997
IT HYDROCOLLOID WITH ZINC
K973855 · FRO
Innovative Technologies , Ltd.
General & Plastic Surgery · 53d
Cleared Dec 01, 1997
BECKMAN URINE PROTEIN CALIBRATOR (UCAL)
K973928 · JIX
Beckman Instruments, Inc.
Chemistry · 47d
Cleared Dec 01, 1997
NON-PRESCRIPTION SUNGLASSES
K974179 · HQY
Taipan Optical Company , Ltd.
Ophthalmic · 25d
Cleared Nov 26, 1997
PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF,...
K964539 · FIP
Zyzatech Water Systems, Inc.
Gastroenterology & Urology · 379d
Cleared Nov 26, 1997
YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT)
K970050 · HCH
Aesculap, Inc.
Neurology · 324d
Cleared Nov 26, 1997
INTELLIFLOW RESPIRATORY ANALYZER
K970840 · BZC
Simtec, Inc.
Anesthesiology · 264d
Cleared Nov 26, 1997
BODYSTAT
K971554 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 210d