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
127153–127176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1990
SUCTION CATHETER STRAIGHT/COUDE
K896730 · BSY
Unoplast A/S
Anesthesiology · 120d
Cleared Mar 30, 1990
OXYGEN CATHETERS
K896731 · BZB
Unoplast A/S
Anesthesiology · 120d
Cleared Mar 30, 1990
COULTER JT3
K896873 · GKZ
Coulter Corp.
Hematology · 112d
Cleared Mar 30, 1990
ATRIUM 2000, CHEST DRAIN
K897125 · KDQ
Atrium Medical Corp.
General Hospital · 94d
Cleared Mar 30, 1990
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
K897133 · CBT
Transidyne General Corp.
Anesthesiology · 93d
Cleared Mar 30, 1990
SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
K897183 · JFL
Beckman Instruments, Inc.
Chemistry · 92d
Cleared Mar 30, 1990
ROCHE REAGENT FOR LDH
K900121 · CFJ
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Mar 30, 1990
HYCOR ACCUPINCH MORPHINE TEST
K900173 · DJG
Hycor Biomedical, Inc.
Toxicology · 77d
Cleared Mar 30, 1990
DELFIA TBG KIT
K900240 · CEE
Pharmacia, Inc.
Chemistry · 72d
Cleared Mar 30, 1990
CANNULA, SUCTION UTERINE
K900641 · HHI
Williams Specialty Products, Inc.
Obstetrics & Gynecology · 49d
Cleared Mar 30, 1990
ENZYMUN TEST(R) PROLACTIN
K900695 · CFT
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared Mar 30, 1990
ITEM #273 CONTACT LENS CASES
K900777 · LRX
Magnivision, Inc.
Ophthalmic · 38d
Cleared Mar 30, 1990
ITEM #272 MAGNIF-EYES CONTACT LENS CASE
K900778 · LRX
Magnivision, Inc.
Ophthalmic · 38d
Cleared Mar 30, 1990
ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
K901086 · KLT
Boehringer Mannheim Corp.
Chemistry · 21d
Cleared Mar 30, 1990
BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER
K901129 · BSO
Medevice, Inc.
Anesthesiology · 18d
Cleared Mar 30, 1990
PULMONAIR 40 PATIENT MANAGEMENT SYSTEM
K901295 · IOQ
The Medical Group, Inc.
Physical Medicine · 10d
Cleared Mar 29, 1990
BARD/ANGIOMED STENTS
K896391 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 143d
Cleared Mar 29, 1990
GLUCOMETER GX BLOOD GLUCOSE METER
K897015 · CGA
Heraeus Kulzer, Inc.
Chemistry · 100d
Cleared Mar 29, 1990
NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
K897072 · KLI
Kallestad Diag, A Div. of Erbamont, Inc.
Chemistry · 97d
Cleared Mar 29, 1990
COULTER CHOLESTEROL REAGENT
K897162 · CHH
Coulter Electronics, Inc.
Chemistry · 91d
Cleared Mar 29, 1990
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
K900009 · KLS
Kallestad Diag, A Div. of Erbamont, Inc.
Toxicology · 86d
Cleared Mar 29, 1990
PERCU-SET(TM)
K900021 · HIO
E-Z-Em, Inc.
Obstetrics & Gynecology · 86d
Cleared Mar 29, 1990
FREE T4 IMMUNOASSAY KIT
K900060 · CEC
Advanced Magnetics, Inc.
Chemistry · 85d
Cleared Mar 29, 1990
EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS
K900680 · HRX
Effner, Inc.
Orthopedic · 45d