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
122401–122424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1991
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
K902405 · CBK
Mallinckrodt Medical
Anesthesiology · 277d
Cleared Mar 04, 1991
AIR PLUS NEBULIZER
K902520 · BTI
Diamond Medical Equipment, Inc.
Anesthesiology · 270d
Cleared Mar 04, 1991
VARIOUS MALE QUICK CONNECTS.
K905091 · BYX
Medical Fittings, Inc.
Anesthesiology · 110d
Cleared Mar 04, 1991
DELUXE SANITARY PAD
K905178 · HHD
American Healthcare Corp.
Obstetrics & Gynecology · 105d
Cleared Mar 04, 1991
NEON RUBBER SUNGLASSES
K905183 · HQZ
Ha-Lo Advertising Specialties, Inc.
Ophthalmic · 105d
Cleared Mar 04, 1991
LAPAROSCOPE
K905196 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 104d
Cleared Mar 04, 1991
KTP DISC KIT
K905424 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Mar 04, 1991
NOBELPHARMA DRILLING EQUIPMENT DEC 500
K905436 · DZE
Nobelpharma USA, Inc.
Dental · 90d
Cleared Mar 04, 1991
SURGICAL FACE MASK
K905749 · FXX
Anago, Inc.
General Hospital · 70d
Cleared Mar 04, 1991
APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM
K905781 · MEH
Intermedics Orthopedics
Orthopedic · 66d
Cleared Mar 04, 1991
GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED
K910108 · JIN
Gds Diagnostics
Chemistry · 53d
Cleared Mar 04, 1991
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · FXX
3M Company
General Hospital · 48d
Cleared Mar 04, 1991
POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
K910252 · HEE
CooperSurgical, Inc.
Obstetrics & Gynecology · 41d
Cleared Mar 04, 1991
OFLOXACIN, 5 MCG SENSI-DISC
K910506 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 27d
Cleared Mar 04, 1991
CANDELA DIODE TRABECULOPLASTY LASER DTL
K910612 · HQF
Candela Laser Corp.
Ophthalmic · 20d
Cleared Mar 01, 1991
NEEDLE, DIALYSIS
K902564 · FIE
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 263d
Cleared Mar 01, 1991
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
K902672 · DTB
Intermedics, Inc.
Cardiovascular · 256d
Cleared Mar 01, 1991
HORIZON 2000 ST ANALYSIS OPTION
K903524 · DPS
Mennen Medical, Inc.
Cardiovascular · 207d
Cleared Mar 01, 1991
MYOTRACK, MODEL HH 515
K904025 · BXN
Myotrack Co.
Anesthesiology · 183d
Cleared Mar 01, 1991
PILLING BRUSH VALVULOTOME
K904507 · DWQ
Pilling Co.
Cardiovascular · 150d
Cleared Mar 01, 1991
MODEL 405
K904606 · DPS
Ivy Biomedical Systems, Inc.
Cardiovascular · 142d
Cleared Mar 01, 1991
TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
K904748 · DRG
Transtracheal Systems
Cardiovascular · 133d
Cleared Mar 01, 1991
TRANSKINETICS RADO FREQ MULTI-LEAD TELE SYST 7200
K904749 · DRQ
Transtracheal Systems
Cardiovascular · 133d
Cleared Mar 01, 1991
NEXUS ACETABULAR CUP
K905408 · JDI
Dow Corning Wright
Orthopedic · 88d