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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
111001–111024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 08, 1993
SUNGLASSES (NON-PRESCRIPTION)
K934374 · HQY
Immmex Company , Ltd.
Ophthalmic · 92d
Cleared Dec 08, 1993
SUNGLASSES
K934403 · HQY
Sun Share Merchandise Corp.
Ophthalmic · 90d
Cleared Dec 08, 1993
SPECTACLE FRAME
K934463 · HQZ
Good Bond Industrial Corp.
Ophthalmic · 89d
Cleared Dec 08, 1993
FEP RINGED GORE-TEX VASCULAR GRAFT
K934726 · DYF
W.L. Gore & Associates, Inc.
Cardiovascular · 68d
Cleared Dec 08, 1993
FINE OPTICS
K934797 · HQZ
Fine Optics, Inc.
Ophthalmic · 63d
Cleared Dec 08, 1993
SUNGLASSES
K934837 · HQY
Simon Marketing, Inc.
Ophthalmic · 64d
Cleared Dec 08, 1993
COOL KIDS HIP SHADES
K934852 · HQY
Ja-Ru, Inc.
Ophthalmic · 57d
Cleared Dec 08, 1993
FRAME SPECTACLE
K934858 · HQZ
Arno Intl., Inc.
Ophthalmic · 57d
Cleared Dec 07, 1993
URETERAL CATHETER
K923729 · EYB
Cook Urological, Inc.
Gastroenterology & Urology · 498d
Cleared Dec 07, 1993
APEC GLUCOSE ANALYZER
K931196 · CGA
Apec, Inc.
Chemistry · 273d
Cleared Dec 07, 1993
PERITEMP PF 4005 HEATER
K932068 · DPW
Perimed, Inc.
Cardiovascular · 222d
Cleared Dec 07, 1993
MICRO EIA FOR AMPHETAMINE METABOLITES
K932304 · DKZ
Microdiagnostics, Inc.
Toxicology · 209d
Cleared Dec 07, 1993
DAMOR CREME
K933328 · MGQ
Damor America, Inc.
General & Plastic Surgery · 152d
Cleared Dec 07, 1993
LAB-SITE(R) SAFETY CANNULA
K933929 · CBF
Migada, Ltd.
Anesthesiology · 119d
Cleared Dec 07, 1993
AIRCAST EDEMAFLOW SYSTEM
K933977 · JOW
Aircast, Inc.
Cardiovascular · 116d
Cleared Dec 07, 1993
DAMOR CREAM SATURATED DRESSING
K934267 · MGQ
Damor America, Inc.
General & Plastic Surgery · 98d
Cleared Dec 07, 1993
STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA
K934376 · DIS
Solarcare, Inc.
Toxicology · 89d
Cleared Dec 07, 1993
TROCAR W/CANNULA, O RING, ADAPTER, AND ADAPTER SLEEVE MODIFICATION
K934534 · GCJ
Baxter Healthcare Corp
General & Plastic Surgery · 81d
Cleared Dec 07, 1993
SPINPRO HDL PRECIPITATING REAGENT
K934801 · LBR
Merchant House Scientific
Chemistry · 61d
Cleared Dec 07, 1993
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
K934898 · CGA
Heraeus Kulzer, Inc.
Chemistry · 55d
Cleared Dec 07, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION
K934900 · CFR
Heraeus Kulzer, Inc.
Chemistry · 55d
Cleared Dec 06, 1993
SPACE LABS MODEL 90560
K923788 · LOS
Spacelabs, Inc.
Cardiovascular · 496d
Cleared Dec 06, 1993
SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.
K924016 · HRX
Symbiosis Corp.
Orthopedic · 482d
Cleared Dec 06, 1993
RX FIT MEDICAL STOCKINGS
K925643 · DWL
Elastic Therapy, Inc.
General Hospital · 392d