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
146113–146136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1985
MICRO THERM MT-500 & MT-600
K854035 · FLL
Medequi, Division of King Yip Co., Inc.
General Hospital · 42d
Cleared Nov 12, 1985
DOUBLE ANTIBODY C-PEPTIDE RIA KIT
K854066 · JKD
Diagnostic Products Corp.
Chemistry · 39d
Cleared Nov 12, 1985
LEUCO PREP
K854093 · JCF
Bd Becton Dickinson Vacutainer...
Hematology · 36d
Cleared Nov 12, 1985
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO
K854108 · LHL
Medical Diagnostic Technologies, Inc.
Microbiology · 35d
Cleared Nov 12, 1985
KODAKEKTACHEM DTR MODULE
K854138 · JJE
Eastman Kodak Company
Chemistry · 33d
Cleared Nov 12, 1985
THE ULTRA-MATE LENS
K854218 · HQG
Optical Systems Intl., Inc.
Ophthalmic · 26d
Cleared Nov 12, 1985
MEBIASIS AGAR GEL DIFFUSION KIT
K854230 · KHW
Lmd Laboratories
Microbiology · 22d
Cleared Nov 12, 1985
THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE
K854244 · HLI
Keeler Instruments, Inc.
Ophthalmic · 22d
Cleared Nov 12, 1985
SPAN / AID SYRINGE
K854255 · FMF
Span-America Medical Systems, Inc.
General Hospital · 21d
Cleared Nov 12, 1985
SUNGLASSES/OPTICAL FRAMES
K854264 · HQY
Wha Chun Industries, Co., Ltd.
Ophthalmic · 20d
Cleared Nov 12, 1985
THAYER-MARTIN MEDIUM (MOD)
K854275 · JTY
R. Kent Richards, Inc.
Microbiology · 25d
Cleared Nov 12, 1985
OPHALMIC LASER PHOTOCOAGULATOR
K854288 · HQF
Mira, Inc.
Ophthalmic · 18d
Cleared Nov 12, 1985
IRON
K854298 · CEM
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Nov 12, 1985
KEYMED OFFICE COUCH
K854304 · FPO
Keymed, Inc.
General Hospital · 18d
Cleared Nov 12, 1985
DART IRON & IRON BINDING CAPACITY REAGENT
K854305 · CFM
Coulter Electronics, Inc.
Chemistry · 18d
Cleared Nov 12, 1985
SIOM
K854343 · HQZ
South West Intl., Inc.
Ophthalmic · 14d
Cleared Nov 12, 1985
KERATOLUX
K854383 · HPL
Carl Zeiss, Inc.
Ophthalmic · 13d
Cleared Nov 08, 1985
CARDIO METRICS INVASIVE PRESSURE MONIT
K841960 · DRS
Sterile Design, Inc.
Cardiovascular · 543d
Cleared Nov 08, 1985
KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR
K851627 · DRW
Eaton Medical Group
Cardiovascular · 204d
Cleared Nov 08, 1985
PCX-100 PATIENT INPUT LEADWIRE
K851632 · DRW
Eaton Medical Group
Cardiovascular · 204d
Cleared Nov 08, 1985
SUPRIMA MODEL 254-22
K852339 · DXY
Intermedics, Inc.
Cardiovascular · 158d
Cleared Nov 08, 1985
SUPRIMA MODEL 254-24
K852340 · DXY
Intermedics, Inc.
Cardiovascular · 158d
Cleared Nov 08, 1985
ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9
K852534 · FTC
R. A. Fischer Co. Corp.
General & Plastic Surgery · 147d
Cleared Nov 08, 1985
NEO SHIELD
K852943 · FMT
Gaymar Industries, Inc.
General Hospital · 120d