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

Filters: Cleared only ×
175,820 results
125377–125400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1990
MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)
K901205 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 153d
Cleared Aug 14, 1990
H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED
K901626 · KWA
Med-Tek Corp.
Orthopedic · 127d
Cleared Aug 14, 1990
LUMISCOPE MICRO 100
K901726 · GZJ
Lumiscope Co., Inc.
Neurology · 120d
Cleared Aug 14, 1990
ONE-LUNG CPAP DEVICE
K901728 · BYE
Vital Signs, Inc.
Anesthesiology · 120d
Cleared Aug 14, 1990
PRECISION MEDICAL OXYGEN REGULATOR
K901831 · CAN
Precision Medical, Inc.
Anesthesiology · 112d
Cleared Aug 14, 1990
DEGUFILL (R) M
K901868 · EBF
Degussa AG
Dental · 112d
Cleared Aug 14, 1990
DEGUFILL (R) H
K901869 · EBF
Degussa AG
Dental · 112d
Cleared Aug 14, 1990
OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER
K901961 · BYX
Medical Fittings, Inc.
Anesthesiology · 105d
Cleared Aug 14, 1990
OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.
K901983 · BYX
Medical Fittings, Inc.
Anesthesiology · 104d
Cleared Aug 14, 1990
OTOSCOPE
K902205 · ERA
Truphatek, Ltd.
Ear, Nose, Throat · 90d
Cleared Aug 14, 1990
READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT
K902236 · GGW
Biosearch Medical Products, Inc.
Immunology · 89d
Cleared Aug 14, 1990
SCALE-TRONIX INCUBATOR SCALE MODEL:4050
K902260 · FRW
Scale-Tronix, Inc.
General Hospital · 85d
Cleared Aug 14, 1990
BARD EXTRACORPOREAL CIRCULATION CANNULAE
K902277 · DWF
C.R. Bard, Inc.
Cardiovascular · 85d
Cleared Aug 14, 1990
THE NAUTILUS NASAL IMPLANT
K902283 · FZE
Applied Biomaterial Technologies
General & Plastic Surgery · 84d
Cleared Aug 14, 1990
CORING NEEDLE (TREPHINE, ORTHOPEDIC)
K902447 · HWE
Biomedtrix, Ltd.
Orthopedic · 74d
Cleared Aug 14, 1990
LONG-LIFE Y-SET CAT. NO. 48-6366-8
K902451 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 74d
Cleared Aug 14, 1990
MODIFIED MOLTENO(TM) IMPLANTS
K902489 · KYF
Iop, Inc.
Ophthalmic · 90d
Cleared Aug 14, 1990
ALLERGAN HUMPHREY A/B SCAN , MODEL 835
K902582 · IYO
Allergan Humphrey
Radiology · 63d
Cleared Aug 14, 1990
ARGENCO M-4 TYPE II DENTAL GOLD ALLOY
K902898 · EJT
Argen Precious Metals, Inc.
Dental · 42d
Cleared Aug 14, 1990
PRECISION MEDICAL DISPOSABLE HUMIDIFIER
K902970 · BTT
Precision Medical, Inc.
Anesthesiology · 39d
Cleared Aug 14, 1990
NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630
K903021 · FJK
National Medical Care, Medical...
Gastroenterology & Urology · 34d
Cleared Aug 14, 1990
ANTI-SCI-70 ANTIBODY TEST
K903314 · LLL
Immco Diagnostics, Inc.
Immunology · 21d
Cleared Aug 14, 1990
BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION
K903360 · DWJ
Augustine Medical, Inc.
Cardiovascular · 29d
Cleared Aug 14, 1990
LIDO LINEA
K903429 · IKK
Loredan Biomedical, Inc.
Physical Medicine · 14d