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
92113–92136 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
K972734 · ETB
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)
K972735 · ETA
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
CAUSSE PISTON
K972737 · ETB
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
HIPALLAUR 19
K972950 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
HIPALLAUR 51
K972951 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
AUREBOND 51
K972952 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALAUREX 76KF
K972953 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALAUREX 78
K972954 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALCERAM 56
K972955 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PALCERAM 82SF
K972956 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 77d
Cleared Sep 05, 1997
PRISMA
K972998 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 04, 1997
AP-4000, AIR PULSE SENSORY STIMULATOR
K964815 · LLN
Pentax Precision Instrument Corp.
Neurology · 279d
Cleared Sep 04, 1997
E. CAM COINCIDENCE MODE (CM)
K970627 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 197d
Cleared Sep 04, 1997
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
K971260 · BTT
ResMed Corp
Anesthesiology · 153d
Cleared Sep 04, 1997
BKMI DISPOSABLE SYRINGE
K971487 · FMI
Sumi Salud C.A.
General Hospital · 134d
Cleared Sep 04, 1997
UNICAP PHADIATOP
K972364 · DHB
Pharmacia, Inc.
Immunology · 71d
Cleared Sep 04, 1997
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
K972367 · KIJ
Stryker Instruments
Orthopedic · 71d
Cleared Sep 04, 1997
RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000
K972441 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 66d
Cleared Sep 04, 1997
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
K972516 · JDS
Synthes (Usa)
Orthopedic · 59d
Cleared Sep 04, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB...
K973030 · JJY
Johnson & Johnson Clinical...
Chemistry · 21d
Cleared Sep 04, 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K973222 · DQA
Siemens Medical Solutions USA, Inc.
Anesthesiology · 14d
Cleared Sep 03, 1997
VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTER
K964908 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 268d
Cleared Sep 03, 1997
CLINIJEL
K970581 · HIS
Hospicon Products
Obstetrics & Gynecology · 201d
Cleared Sep 03, 1997
FACE MASK, SURGICAL MASK, NON-STERILE
K970835 · FXX
Tucker & Associates
General Hospital · 196d