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
111097–111120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1993
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K932098 · BZK
Datex Division Instrumentarium Corp.
Anesthesiology · 210d
Cleared Nov 29, 1993
INJECTION SITE
K932446 · FPA
3M Health Care, Ltd.
General Hospital · 193d
Cleared Nov 29, 1993
BATROXOBIN REAGENT
K932787 · JCO
Behring Diagnostics, Inc.
Hematology · 173d
Cleared Nov 29, 1993
BISCO UNIVERSAL HYBRID COMPOSITE
K934247 · EBF
Bisco, Inc.
Dental · 91d
Cleared Nov 29, 1993
OMNI 2000 SERIES ITE HEARING AID
K934416 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 29, 1993
OMNI 2000 SERIES ITC HEARING AID
K934417 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 77d
Cleared Nov 29, 1993
UNITRON MODEL IKON AGCO/ AOD
K934565 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 74d
Cleared Nov 29, 1993
CORE PREVENT MATTRESS MODIFICATION
K935220 · FMW
Paladin Medical, Inc.
General Hospital · 48d
Cleared Nov 26, 1993
UROPAPER EIKEN AG
K932365 · JIL
Tanabe U.S.A., Inc.
Chemistry · 221d
Cleared Nov 26, 1993
UROPAPER EIKEN HAG
K932366 · JIL
Tanabe U.S.A., Inc.
Chemistry · 221d
Cleared Nov 26, 1993
PARAMAX(R) PHENYTOIN REAGENT
K932686 · DIP
Baxter Diagnostics, Inc.
Toxicology · 176d
Cleared Nov 26, 1993
U-TROL LIQUID URINE DIPSTICK CONTROL
K934257 · JJW
P.T. Meditrol
Chemistry · 87d
Cleared Nov 26, 1993
SPQ MALB CONTROL LEVEL II
K934521 · JJX
Incstar Corp.
Chemistry · 70d
Cleared Nov 26, 1993
BUN-300/BUN-500 UREA NITROGEN REAGENT
K934533 · CDQ
Horizon Diagnostics, Inc.
Chemistry · 70d
Cleared Nov 24, 1993
BD6000 THE OPTIMA & BD5000 BIRTHING BED
K914544 · KNC
Lic Care, Inc.
Obstetrics & Gynecology · 776d
Cleared Nov 24, 1993
VASCOTWIST 9/60
K920662 · DTB
Vascor Medical Corp.
Cardiovascular · 649d
Cleared Nov 24, 1993
LSP (MODEL 554) BAG MASK RESUSCITATOR
K922691 · BTM
Life Support Products, Inc.
Anesthesiology · 538d
Cleared Nov 24, 1993
INFANT DISPOSABLE BAG MASK RESUSCITATOR
K922819 · BTM
Life Support Products, Inc.
Anesthesiology · 531d
Cleared Nov 24, 1993
MEDISON 1500
K924432 · IYO
Medison Co., Ltd.
Radiology · 449d
Cleared Nov 24, 1993
DELTATRAC(TM) II METABOLIC MONITOR
K931422 · BZL
Datex Division Instrumentarium Corp.
Anesthesiology · 247d
Cleared Nov 24, 1993
LSPI AUTOMATIC VENTILATOR, MODEL AV3000
K932199 · BTL
Life Support Products, Inc.
Anesthesiology · 202d
Cleared Nov 24, 1993
LSPI AUTOMATIC VENTILATOR
K932200 · BTL
Life Support Products, Inc.
Anesthesiology · 202d
Cleared Nov 24, 1993
TRI-MED PARACENTESIS TRAY
K932652 · LRO
Tri-Med Specialties, Inc.
General & Plastic Surgery · 175d
Cleared Nov 24, 1993
SELECTOR SL 01
K933220 · EWO
Futuremed Div. of Future Impex Corp.
Ear, Nose, Throat · 146d