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
112633–112656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 1993
ALIBI OPTICAL FRAMES AND SUNGLASSES
K925187 · HQY
Alibi Designs, Inc.
Ophthalmic · 352d
Cleared Oct 01, 1993
SUNGLASSES
K925570 · HQY
De'Vons Products, Inc.
Ophthalmic · 332d
Cleared Oct 01, 1993
SENTRY POSTERIOR SPINAL SYSTEM
K930710 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 232d
Cleared Oct 01, 1993
SENTRY ANTERIOR SPINAL SYSTEM
K930807 · KWQ
Sofamor Danek Mfg., Inc.
Orthopedic · 227d
Cleared Oct 01, 1993
ITEM # 755 HOT SUNGLASSES
K931055 · HQY
South American Industrial Co.
Ophthalmic · 232d
Cleared Oct 01, 1993
PACEART CARDIOPHONE
K931296 · DXH
Paceart, Inc.
Cardiovascular · 185d
Cleared Oct 01, 1993
IL TEST URIC ACID
K931350 · KNK
Instrumentation Laboratory CO
Chemistry · 198d
Cleared Oct 01, 1993
SUNGLASSES
K931408 · HQY
Sunnycraft Philippines, Inc.
Ophthalmic · 196d
Cleared Oct 01, 1993
FLOATER SUNGLASSES
K931431 · HQY
Floater Eyewear, Inc.
Ophthalmic · 193d
Cleared Oct 01, 1993
MINI-LANCET
K931481 · FMK
Pacific Rim Products, Inc.
General & Plastic Surgery · 191d
Cleared Oct 01, 1993
BRILLENERZEUGUNG POMBERGER OR MULTIPLE SUNGLASSES
K931910 · HQY
Brillenerzeugung Pomberger
Ophthalmic · 168d
Cleared Oct 01, 1993
BRILLENERZEUGUNG POMBERGER OR MULTIPLE SPEC FRAMES
K931911 · HQZ
Brillenerzeugung Pomberger
Ophthalmic · 168d
Cleared Oct 01, 1993
FRAME - SPECTACLE
K931972 · HQZ
Eyetel Optics, Inc.
Ophthalmic · 162d
Cleared Oct 01, 1993
OPTICAL ACCESSORIES-SPECTACLE FRAMES AND SUNGLASSES
K932125 · HQZ
Vision Design Eyewear, Inc.
Ophthalmic · 151d
Cleared Oct 01, 1993
SOLOSITE DERMAL WOUND GEL
K932263 · MGQ
Smith & Nephew United, Inc.
General & Plastic Surgery · 164d
Cleared Oct 01, 1993
SUNGLASSES
K932275 · HQY
Kam Cheong Plastic Factory , Ltd.
Ophthalmic · 142d
Cleared Oct 01, 1993
EMIT(R) THC 50/100 NG ASSAY
K932716 · LDJ
Syva Co.
Toxicology · 119d
Cleared Oct 01, 1993
THERAPEUTIC STIMULATOR 300(TS-300) & 300P(TS-300P)
K932764 · IPF
Myo/Kinetic Systems, Inc.
Physical Medicine · 115d
Cleared Oct 01, 1993
SPECTACLE FRAMES
K932992 · HQZ
Vivid Optical Co., Ltd.
Ophthalmic · 105d
Cleared Oct 01, 1993
INFLUENCE,ARIA,MASERATI,ROCHAS,ANGELO,TARLAZZI
K933138 · HQY
Aria Advanced Eyewear, Inc.
Ophthalmic · 95d
Cleared Oct 01, 1993
PROCEDURE KITS
K933160 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 94d
Cleared Oct 01, 1993
PRINCE
K933309 · EJJ
Goldsmith & Revere, Inc.
Dental · 86d
Cleared Oct 01, 1993
SALINE SOLUTION-STERILE
K933412 · JOH
Trinity Laboratories, Inc.
Anesthesiology · 80d
Cleared Oct 01, 1993
MULTIPLE
K933429 · HQZ
Sam Chung Optical Co., Ltd.
Ophthalmic · 80d