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
120505–120528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1991
PROSPEC T/GIARDIA RAPID ASSAY
K911337 · MHI
Alexon, Inc.
Microbiology · 185d
Cleared Sep 27, 1991
PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE
K911366 · GXY
Medical Design & Manufacturing Corp.
Neurology · 183d
Cleared Sep 27, 1991
INTERSON DISPOSABLE BIOPSY NEEDLE
K911464 · IYO
Interson Corp.
Radiology · 177d
Cleared Sep 27, 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON
K911630 · FGE
Baxter Healthcare Corp
Gastroenterology & Urology · 169d
Cleared Sep 27, 1991
MENTOR BLACK LIGHT INJECTION STENT SET
K912060 · FAD
Mentor Corp.
Gastroenterology & Urology · 141d
Cleared Sep 27, 1991
SAFEWEDGE(TM) RELIEF VALVE DEVICE
K912172 · KRB
Sunscope Intl., Inc.
Cardiovascular · 134d
Cleared Sep 27, 1991
SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200
K912447 · FET
Medical Laser, Inc.
Gastroenterology & Urology · 116d
Cleared Sep 27, 1991
KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE
K912454 · JAK
Eastman Kodak Company
Radiology · 116d
Cleared Sep 27, 1991
KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST
K912499 · CHH
King Diagnostics, Inc.
Chemistry · 114d
Cleared Sep 27, 1991
SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM
K912539 · LNH
GE Medical Systems
Radiology · 109d
Cleared Sep 27, 1991
ROCHE COBAS ARGOS 5 DIFF
K912615 · GZI
Roche Diagnostic Systems, Inc.
Hematology · 106d
Cleared Sep 27, 1991
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K912754 · DPJ
Roche Diagnostic Systems, Inc.
Toxicology · 98d
Cleared Sep 27, 1991
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
K912838 · LKT
Baxter Diagnostics, Inc.
Microbiology · 93d
Cleared Sep 27, 1991
STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO
K912852 · JLW
Baxter Healthcare Corp
Chemistry · 91d
Cleared Sep 27, 1991
HEIDELBERG RETINA TOMOGRAPH
K912891 · HLI
Heidelberg Engineering
Ophthalmic · 88d
Cleared Sep 27, 1991
APR COLLAR SPACER
K912916 · JDI
Intermedics Orthopedics
Orthopedic · 86d
Cleared Sep 27, 1991
ENDOSCOPE SUTURE & CARRIER
K912973 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 81d
Cleared Sep 27, 1991
OPERAND LUBRICATING JELLY
K912975 · KMJ
General Medical Co.
General Hospital · 81d
Cleared Sep 27, 1991
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · KHO
Baxter Healthcare Corp
Chemistry · 73d
Cleared Sep 27, 1991
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
K913133 · JJY
Bionostics, Inc.
Chemistry · 73d
Cleared Sep 27, 1991
ENZYMUN-TEST ESTRADIOL
K913162 · CHP
Boehringer Mannheim Corp.
Chemistry · 72d
Cleared Sep 27, 1991
AIA-PACK CK-MB
K913298 · JHX
Tosoh Corp.
Chemistry · 64d
Cleared Sep 27, 1991
LATEX EXAMINATION GLOVES
K913409 · LYY
Top Glove Sdn. Bhd.
General Hospital · 59d
Cleared Sep 27, 1991
CEDIA(R) GENTAMICIN ASSAY
K913470 · LCD
Microgenics Corp.
Toxicology · 53d