FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
115033–115056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1993
SYMBIOSIS DISPOSABLE ARTHROSCOPIC SURGICAL INST.
K924017 · HRX
Symbiosis Corp.
Orthopedic · 217d
Cleared Mar 16, 1993
I.V. PRO
K924180 · KMK
I.V. - Pro Tek, Inc.
General Hospital · 209d
Cleared Mar 16, 1993
MICRODOSE PORCELAIN ETCHANT
K924821 · ELL
Unicep
Dental · 169d
Cleared Mar 16, 1993
MICRODOSE SILANE
K924823 · ELL
Unicep
Dental · 169d
Cleared Mar 16, 1993
MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE
K924824 · EBC
Unicep
Dental · 169d
Cleared Mar 16, 1993
MICRODOSE DENTIN CONDITIONER
K925162 · EBF
Unicep
Dental · 154d
Cleared Mar 16, 1993
OTI ORTHOPEDIC FASTENER SYSTEM
K925301 · HTY
Osteo Technology, Inc.
Orthopedic · 146d
Cleared Mar 16, 1993
COMFEEL(R) WOUND DRESSING SD
K925376 · KMF
Coloplast A/S
General & Plastic Surgery · 144d
Cleared Mar 16, 1993
VERASOFT CASTING ALLOY
K925579 · EJH
Aalba Dent, Inc.
Dental · 132d
Cleared Mar 16, 1993
BREAST STABILIZER
K925874 · MDM
Bip USA, Inc.
General & Plastic Surgery · 117d
Cleared Mar 16, 1993
ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES
K925996 · HRX
Arthrex, Inc.
Orthopedic · 109d
Cleared Mar 16, 1993
ARTHROSCOPIC KNEE INSTRUMENTS
K926062 · HRX
Arthrex, Inc.
Orthopedic · 105d
Cleared Mar 16, 1993
PULPDENT DENTAL BOND ENCHANCER
K926074 · EBF
Pulpdent Corp.
Dental · 105d
Cleared Mar 16, 1993
ARTHROSCOPIC KNEE INSTRUMENTS
K926111 · HRX
Arthrex, Inc.
Orthopedic · 103d
Cleared Mar 16, 1993
ARTHREX INSTRUMENTS (SHOULDER GP. 1)
K926193 · HRX
Arthrex, Inc.
Orthopedic · 97d
Cleared Mar 16, 1993
FLEXIBLE TROCAR TUBES
K930215 · EWY
Olympus Corp.
Ear, Nose, Throat · 61d
Cleared Mar 16, 1993
CLINICAL NEURO SYSTEMS CRANIAL DRILL
K930229 · HBE
Clinical Neuro Systems, LLC
Neurology · 56d
Cleared Mar 16, 1993
QUANTA LITE(TM) THYROID M ELISA
K930485 · JZO
Inova Diagnostics, Inc.
Immunology · 46d
Cleared Mar 15, 1993
DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE
K922100 · EJJ
Graham Medical Products
Dental · 315d
Cleared Mar 15, 1993
PRO-LOK EXTENSION SET(S)
K922469 · FPA
Vlv Associates, Inc.
General Hospital · 293d
Cleared Mar 15, 1993
OLYMPUS OES LAPAROSCOPY SYSTEM
K923982 · GCJ
Olympus Corp.
General & Plastic Surgery · 220d
Cleared Mar 15, 1993
DOCTOR'S CHOICE LATEX EXAMINATION GLOVES
K924265 · LYY
Chesire Laboratories
General Hospital · 203d
Cleared Mar 15, 1993
OVERTUBE FOR ENDSCOPIC LIGATOR
K924764 · MNK
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 173d
Cleared Mar 15, 1993
RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)
K925929 · LMD
Rstar, Inc.
Radiology · 112d