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
85273–85296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1999
OCUSYSTEM ART ADVANTAGE, MODEL 995
K991852 · HQC
Surgical Design Corp.
Ophthalmic · 36d
Cleared Jul 07, 1999
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
K992054 · LPL
Adventures IN Color Technology, Ltd.
Ophthalmic · 20d
Cleared Jul 06, 1999
TAMPA HYPERBARIC MONOPLACE CHAMBER
K981938 · CBF
Tampa Hyperbaric Ent.
Anesthesiology · 399d
Cleared Jul 06, 1999
DURAGEN DURAL GRAFT MATRIX
K982180 · GXQ
Integra Lifesciences Corp.
Neurology · 379d
Cleared Jul 06, 1999
LIFESTYLES XTRA PLEASURE
K983518 · HIS
Ansell, Inc.
Obstetrics & Gynecology · 272d
Cleared Jul 06, 1999
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · FFS
Smith & Nephew, Inc.
Gastroenterology & Urology · 78d
Cleared Jul 06, 1999
QUADRATURE WRIST COIL, MODEL 445PH-64
K991434 · MOS
Medical Advances, Inc.
Radiology · 71d
Cleared Jul 06, 1999
IMMERGE IMAGE CORRELATION
K991468 · LLZ
Surgical Navigation Technologies, Inc.
Radiology · 70d
Cleared Jul 06, 1999
SAMSUNG RAYPAX SYSTEM
K991537 · LMD
Samsung Sds Co., Ltd.
Radiology · 64d
Cleared Jul 06, 1999
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR...
K991955 · BTM
Engineered Medical Systems
Anesthesiology · 35d
Cleared Jul 06, 1999
STATUS STIK, ACCUSIGN STIK
K992068 · DKE
Princeton BioMeditech Corp.
Toxicology · 18d
Cleared Jul 06, 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · CEW
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jul 02, 1999
DD URETERAL STENT, INTEGRAL STENT
K982974 · FAD
Rusch Intl.
Gastroenterology & Urology · 311d
Cleared Jul 02, 1999
MODIFICATION TO GAMMA GUIDANCE SYSTEM
K983768 · IZD
Radiation Monitoring Devices, Inc.
Radiology · 249d
Cleared Jul 02, 1999
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
K991170 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 86d
Cleared Jul 02, 1999
MODIFIED HAM'S F-10 WITH ALBUMIN
K991420 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 70d
Cleared Jul 02, 1999
FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM...
K991421 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 70d
Cleared Jul 02, 1999
WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
K991626 · LLZ
Analogic Corp.
Radiology · 52d
Cleared Jul 01, 1999
AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
K983631 · CBP
Instrumentation Industries, Inc.
Anesthesiology · 259d
Cleared Jul 01, 1999
HEDROCEL ACETABULAR CAGE SYSTEM
K983837 · LPH
Implex Corp.
Orthopedic · 244d
Cleared Jul 01, 1999
THERMAL ANGEL
K984640 · BSB
Estill Medical Technologies, Inc.
Hematology · 182d
Cleared Jul 01, 1999
BIO-INTERFERENCE SCREW
K990454 · HWC
Innovasive Devices, Inc.
Orthopedic · 139d
Cleared Jul 01, 1999
ANESFLOW-DUAL DRIP IV INFUSION SET
K990496 · FPA
Innovative Design Assoc.
General Hospital · 134d
Cleared Jul 01, 1999
RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES
K990602 · QPB
Tecsa Technical Services
General & Plastic Surgery · 127d