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
116953–116976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 1992
SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES
K922011 · JAA
Shimadzu Medical Systems
Radiology · 42d
Cleared Jun 10, 1992
SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES
K922013 · JAA
Shimadzu Medical Systems
Radiology · 42d
Cleared Jun 10, 1992
BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL)
K922301 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 26d
Cleared Jun 10, 1992
4 SURE TM COLOSTOMY POUCH
K922401 · EZQ
Boston Pacific Medical, Inc.
Gastroenterology & Urology · 20d
Cleared Jun 10, 1992
PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES
K922422 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 20d
Cleared Jun 09, 1992
DURA MATER
K910447 · LEM
Lifelink Foundation Tissue Bank
Neurology · 508d
Cleared Jun 09, 1992
INVALIFT
K910830 · FRZ
American Invalift Corp.
General Hospital · 468d
Cleared Jun 09, 1992
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE
K914194 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 265d
Cleared Jun 09, 1992
SEROELISA(TM) CHLAMYDIA IGA TEST KIT
K914327 · LJC
Savyon Diagnostics , Ltd.
Microbiology · 256d
Cleared Jun 09, 1992
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
K915723 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 172d
Cleared Jun 09, 1992
ACCESS QD HEAD COIL
K920098 · LNH
Toshiba America Mri, Inc.
Radiology · 153d
Cleared Jun 09, 1992
TB SUSCEPTIBILITY QUADS I AND II
K920143 · MJD
Remel Co.
Microbiology · 148d
Cleared Jun 09, 1992
HERMLE Z230H
K920207 · GKG
Labnet Intl., Inc.
Hematology · 145d
Cleared Jun 09, 1992
BACTIDROP KOH (10%)
K920970 · JTS
Remel Co.
Pathology · 99d
Cleared Jun 09, 1992
BACTIDROP CALCOFLUOR WHITE
K920975 · JTS
Remel Co.
Pathology · 99d
Cleared Jun 09, 1992
BACTIDROP INDIA INK
K920976 · JTS
Remel Co.
Pathology · 99d
Cleared Jun 09, 1992
SNOWDEN-PENCER IRRIGATION PUMP
K920985 · HEI
Snowden-Pencer
Obstetrics & Gynecology · 99d
Cleared Jun 09, 1992
STERILE/SINGLE USE OPHTHALMIC CONFORMERS
K921229 · HQN
Storz Instrument Co.
Ophthalmic · 88d
Cleared Jun 09, 1992
KEANE UNI KNEE SYSTEM WITH POROCOAT
K921232 · HSX
Depuy, Inc.
Orthopedic · 88d
Cleared Jun 09, 1992
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2
K921286 · JJY
Bio-Rad
Chemistry · 84d
Cleared Jun 09, 1992
GLYCO-TEK AFFINITY COLUMN KIT
K921305 · LCP
Helena Laboratories
Hematology · 89d
Cleared Jun 09, 1992
THROMBO-CALIBRATOR KIT
K921344 · GGN
American Bioproducts Co.
Hematology · 82d
Cleared Jun 09, 1992
CASCADE 480
K921363 · GKP
Helena Laboratories
Hematology · 81d
Cleared Jun 09, 1992
IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE
K921378 · FRN
Imed Corp.
General Hospital · 78d