FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83137–83160 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 2000
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY...
K000376 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 43d
Cleared Mar 21, 2000
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT...
K000529 · LPL
The Lifestyle Co., Inc.
Ophthalmic · 33d
Cleared Mar 21, 2000
ELECSYS CORTISOL CALCHECK
K000576 · JIX
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Mar 21, 2000
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
K000728 · FST
Medtronic Xomed
General & Plastic Surgery · 15d
Cleared Mar 21, 2000
CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
K992703 · DQK
Premier Heart, LLC
Cardiovascular · 222d
Cleared Mar 21, 2000
OVES CERVICAL CAP
K993953 · HDR
Veos , Ltd.
Obstetrics & Gynecology · 120d
Cleared Mar 21, 2000
MALE LATEX CONDOM WITH VANILLA FLAVOR
K994311 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 90d
Cleared Mar 21, 2000
MALE LATEX CONDOM 56MM
K994312 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 90d
Cleared Mar 21, 2000
I-PLANT, MODEL 3500
K994317 · KXK
Implant Sciences Corp.
Radiology · 90d
Cleared Mar 21, 2000
NEUROTHERM RF CANNULA
K994344 · GXI
Rocket Medical Plc
Neurology · 90d
Cleared Mar 21, 2000
BOND 1 C & B
K994359 · KLE
Jeneric/Pentron, Inc.
Dental · 85d
Cleared Mar 20, 2000
RADIONICS LUMBOPERITONEAL SHUNT
K000057 · JXG
Radionics, Inc.
Neurology · 70d
Cleared Mar 20, 2000
AVL OPTI R ANALYZER
K000103 · CHL
Avl Scientific Corp.
Chemistry · 67d
Cleared Mar 20, 2000
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES,...
K000439 · LPL
Wesley Jessen Corp.
Ophthalmic · 39d
Cleared Mar 20, 2000
VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR...
K000488 · LYY
Sgmp Co., Ltd.
General Hospital · 35d
Cleared Mar 20, 2000
MODIFICATION TO HP M2376A DEVICE LINK SYSTEM
K000635 · MWI
Agilent Technologies, Inc.
Cardiovascular · 24d
Cleared Mar 20, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
K000716 · JHX
Beckman Coulter, Inc.
Chemistry · 17d
Cleared Mar 20, 2000
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR...
K991840 · HKY
Bernard B. Fresco
Ophthalmic · 297d
Cleared Mar 20, 2000
VISAGE COSMETIC SURGERY, MODEL V5000
K992180 · GEI
Arthrocare Corp.
General & Plastic Surgery · 266d
Cleared Mar 20, 2000
BIPAP SYNCHRONY HC
K992530 · MNS
Respironics, Inc.
Anesthesiology · 236d
Cleared Mar 20, 2000
BLADEWORKS MICROKERATOME BLADE
K993225 · HNO
Blade Works, Inc.
Ophthalmic · 175d
Cleared Mar 20, 2000
ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS
K993343 · LKY
Erecxel Enterprises
Gastroenterology & Urology · 167d
Cleared Mar 20, 2000
IOLMASTER
K993357 · HJO
Carl Zeiss, Inc.
Ophthalmic · 166d
Cleared Mar 20, 2000
LOVE LOCKERS
K993733 · HIS
Medtech Products , Ltd.
Obstetrics & Gynecology · 137d