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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141145–141168 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1987
DART PHENOBARBITAL ASSAY SYSTEM
K864612 · LFN
Coulter Electronics, Inc.
Toxicology · 50d
Cleared Jan 13, 1987
FOUR TANK DISSOLUTION MODULE
K864635 · FKQ
National Medical Care, Medical...
Gastroenterology & Urology · 49d
Cleared Jan 13, 1987
UREA NITROGEN(BUN), COLORIMETRIC METHOD
K864742 · CDL
Tech-Co, Inc.
Chemistry · 40d
Cleared Jan 13, 1987
BIURET (COLORIMETRIC), TOTAL PROTEIN
K864743 · CEK
Tech-Co, Inc.
Chemistry · 40d
Cleared Jan 13, 1987
CREATINE PHOSPHOKINASE (CK)
K864744 · CGS
Tech-Co, Inc.
Chemistry · 40d
Cleared Jan 13, 1987
DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)
K864863 · JKA
Dynatech Laboratories, Inc.
Chemistry · 33d
Cleared Jan 13, 1987
ALKALINE PHOSPHATASE
K864905 · CJE
Tech-Co, Inc.
Chemistry · 29d
Cleared Jan 13, 1987
H-H SUBGALEAL TROCAR
K865075 · GYK
Holter-Hausner Intl.
Neurology · 15d
Cleared Jan 13, 1987
IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
K865102 · LES
Sclavo, Inc.
Toxicology · 20d
Cleared Jan 12, 1987
EDP-20 PACEMAKER
K860036 · DXY
Biotronik Sales, Inc.
Cardiovascular · 371d
Cleared Jan 12, 1987
ARKIVE (TM)
K862085 · BSZ
Diatek, Inc.
Anesthesiology · 224d
Cleared Jan 12, 1987
HEATED JET HUMIDIFIER MODEL AMS-1020
K863154 · BTT
Acutronic Medical Systems AG
Anesthesiology · 150d
Cleared Jan 12, 1987
PATIENT VALVE WITH AIR ENTRAINMENT
K863410 · BTL
Pneupac , Ltd.
Anesthesiology · 173d
Cleared Jan 12, 1987
TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR
K863801 · CBS
Traverse Medical Monitors
Anesthesiology · 105d
Cleared Jan 12, 1987
OHMEDA 6000 MULTI-GAS MONITOR
K863959 · JJQ
Ohmeda Medical
Chemistry · 94d
Cleared Jan 12, 1987
MINGOGRAF 410
K864009 · DPS
Siemens Medical Solutions USA, Inc.
Cardiovascular · 89d
Cleared Jan 12, 1987
PROCON
K864218 · KNT
Healthcare Management Systems
Gastroenterology & Urology · 76d
Cleared Jan 12, 1987
BARD HARVARD MINI-INFUSER 950 PUMP
K864233 · FRN
C.R. Bard, Inc.
General Hospital · 76d
Cleared Jan 12, 1987
PEDIATRIC BELLOWS
K864431 · CBK
Draeger Medical, Inc.
Anesthesiology · 61d
Cleared Jan 12, 1987
PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK
K864472 · CBP
Tagg Industries
Anesthesiology · 60d
Cleared Jan 12, 1987
OHMEDA 5500 AIRWAY PRESSURE MONITOR
K864536 · CAP
Ohmeda Medical
Anesthesiology · 56d
Cleared Jan 12, 1987
BIRD 6500 AIR COMPRESSOR
K864547 · BTI
Bird Products Corp.
Anesthesiology · 54d
Cleared Jan 12, 1987
BOARD, ARM (WITH COVER)
K864670 · BTX
Anago, Inc.
General & Plastic Surgery · 41d
Cleared Jan 12, 1987
ARNOLD-KING PRESSURE DRESSING
K864688 · NAD
Angiosystems, Inc.
General & Plastic Surgery · 41d