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
116017–116040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1992
OPTICAL FRAMES
K922930 · HQZ
St. Germain Eyewear Intl.
Ophthalmic · 92d
Cleared Sep 17, 1992
STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY
K923286 · CGN
Baxter Diagnostics, Inc.
Toxicology · 73d
Cleared Sep 17, 1992
IL TEST ALT, PN 35311
K923623 · CKA
Instrumentation Laboratory CO
Chemistry · 58d
Cleared Sep 17, 1992
LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
K924217 · BTM
Life Support Products, Inc.
Anesthesiology · 29d
Cleared Sep 16, 1992
NEOLINE(TM)
K914778 · CBT
Martech Medical Products, Inc.
Anesthesiology · 329d
Cleared Sep 16, 1992
EDM(R) INFUSION CATHETER
K914979 · KRA
Peripheral Systems Group
Cardiovascular · 315d
Cleared Sep 16, 1992
PALADUR
K915898 · EBI
Heraeus Kulzer, Inc.
Dental · 309d
Cleared Sep 16, 1992
CLEARTRAC CANNULA
K920454 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 225d
Cleared Sep 16, 1992
ORIGIN SECONDARY CANNULA AND TROCAR
K922460 · GEA
Origin Medsystems, Inc.
General & Plastic Surgery · 113d
Cleared Sep 16, 1992
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
K924215 · BTM
Ambu, Inc.
Anesthesiology · 43d
Cleared Sep 16, 1992
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
K924216 · BTM
Ambu, Inc.
Anesthesiology · 43d
Cleared Sep 15, 1992
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS
K914488 · CAW
Invacare Corp.
Anesthesiology · 343d
Cleared Sep 15, 1992
ULTRACELL INSTRUMENT WIPE
K920353 · HEP
Ultracell Medical Technologies, Inc.
Obstetrics & Gynecology · 232d
Cleared Sep 15, 1992
MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS
K920889 · DTZ
Medtronic Vascular
Cardiovascular · 216d
Cleared Sep 15, 1992
CENTRI-SAFE(TM) VALVE
K921500 · MJJ
Cardio Systems, Inc.
Cardiovascular · 168d
Cleared Sep 15, 1992
CN ENDOTRACHEAL TUBE HOLDER
K921698 · CBH
N-C-N Products Co.
Anesthesiology · 160d
Cleared Sep 15, 1992
SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT
K922262 · LRJ
Sporicidin Intl.
General Hospital · 126d
Cleared Sep 15, 1992
YASARGIL ANEURYSM CLIPS
K922272 · HCH
Aesculap, Inc.
Neurology · 124d
Cleared Sep 15, 1992
ONE TOUCH IIB BLOOD GLUCOSE METER
K922888 · CGA
Lifescan, Inc.
Chemistry · 91d
Cleared Sep 15, 1992
J-VAC BULB SUCTION RESERVOIR
K922895 · GCY
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 91d
Cleared Sep 15, 1992
STRAPPAL
K922897 · KGX
Smith & Nephew United, Inc.
General & Plastic Surgery · 91d
Cleared Sep 15, 1992
NE-U07
K922923 · CAF
Omron Healthcare, Inc.
Anesthesiology · 90d
Cleared Sep 15, 1992
NE-U04/NE U04F
K923024 · CAF
Omron Healthcare, Inc.
Anesthesiology · 84d
Cleared Sep 15, 1992
ANI BIOCARD HCG TEST
K923030 · JHI
Ani OY
Chemistry · 84d