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
142273–142296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 1986
SENSORMEDICS OXYSHUTTLE(TM)
K862617 · DQA
Sensor Medics Corp.
Anesthesiology · 79d
Cleared Sep 26, 1986
EUROCART SR-4, EUROCART M-IV, ISOCART III
K863010 · EIA
Sds Dental, Inc.
Dental · 49d
Cleared Sep 26, 1986
BILIRUBIN TOTAL DIRECT
K863057 · CIG
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
CALCIOMETER
K863059 · CIA
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
TRIGLYCERIDES-E
K863075 · CDT
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
ACE II (TRI-LEVEL)
K863095 · JIX
Medical Analysis Systems, Inc.
Chemistry · 44d
Cleared Sep 26, 1986
URIC ACID PROCEDURE
K863251 · KNK
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
TRIGLYCERIDE (TRINDER) PROCEDURE
K863254 · CDT
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
CALCIUM PROCEDURE
K863256 · CIC
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
AST/GOT PROCEDURE
K863257 · CIT
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
GLUCOSE HK PROCEDURE
K863259 · CFR
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
DEMAND TOTAL PROTEIN
K863301 · CEK
Cooper Biomedical, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST
K863328 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 30d
Cleared Sep 26, 1986
ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR
K863329 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 30d
Cleared Sep 26, 1986
FORMALENS 2000
K863367 · HQG
Vision-Sciences, Inc.
Ophthalmic · 23d
Cleared Sep 26, 1986
DERMATEC BURN PADS
K863379 · NAD
Dermatec, Inc.
General & Plastic Surgery · 23d
Cleared Sep 26, 1986
DELFIA(TM) CORTISOL KIT
K863422 · JFT
Lkb Instruments, Inc.
Chemistry · 22d
Cleared Sep 26, 1986
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
K863477 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 26, 1986
RAICHEM(TM) CHLORIDE REAGENT
K863620 · CHJ
Reagents Applications, Inc.
Chemistry · 10d
Cleared Sep 26, 1986
QUANTIMAP III
K863650 · OLT
Quantified Signal Imaging, Inc.
Neurology · 8d
Cleared Sep 26, 1986
LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50
K863706 · HIS
Manexim Multicorp, Ltd.
Obstetrics & Gynecology · 3d
Cleared Sep 26, 1986
LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40
K863707 · HIS
Manexim Multicorp, Ltd.
Obstetrics & Gynecology · 3d
Cleared Sep 25, 1986
RSL (125I) ALDOSTERONE KIT
K862204 · CJM
Radioassay Systems Laboratories, Inc.
Chemistry · 107d
Cleared Sep 25, 1986
PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
K862336 · CGR
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 97d