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
94177–94200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 18, 1997
LASER EYE GOGGLES
K970361 · GEX
Stefanovsky & Assoc.
General & Plastic Surgery · 46d
Cleared Mar 18, 1997
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
K970467 · CEP
Excel Scientific, Inc.
Chemistry · 39d
Cleared Mar 18, 1997
PATIENT EXAMINATION GLOVES (POWDER FREE-NON STERILE)
K970613 · LYY
Sti Medical Sdn Bhd
General Hospital · 28d
Cleared Mar 18, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL...
K970643 · CHP
Johnson & Johnson Clinical...
Chemistry · 26d
Cleared Mar 18, 1997
S.P. 100
K970696 · GZJ
Lsi Intl., Inc.
Neurology · 21d
Cleared Mar 17, 1997
ABC IN-LINE BLOOD SAMPLING KIT
K955663 · CBT
Utah Medical Products, Inc.
Anesthesiology · 460d
Cleared Mar 17, 1997
KIRSCHNER KNEE MODIFIED
K961021 · JWH
Biomet, Inc.
Orthopedic · 368d
Cleared Mar 17, 1997
CPC PROBE
K961380 · GEX
Carl Zeiss, Inc.
General & Plastic Surgery · 341d
Cleared Mar 17, 1997
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 266d
Cleared Mar 17, 1997
VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE
K963315 · IYO
Vingmed Sound, Inc.
Radiology · 207d
Cleared Mar 17, 1997
EMERGENCY RELIEF KIT SYSTEM
K964029 · LRR
Baxter Healthcare Corp
General & Plastic Surgery · 161d
Cleared Mar 17, 1997
MCL 29 DERMABLATE ERBIUM LASER SYSTEM
K964128 · GEX
Aesculap-Meditec GmbH
General & Plastic Surgery · 153d
Cleared Mar 17, 1997
SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD...
K964416 · KWQ
Synthes (Usa)
Orthopedic · 164d
Cleared Mar 17, 1997
ELEVATING AND REMOVABLE LEG AND REMOVABLE ARM WHEELCHAIR
K964932 · IOR
L & M Resource Information Service, Inc.
Physical Medicine · 98d
Cleared Mar 17, 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR...
K964987 · DSP
Datascope Corp.
Cardiovascular · 94d
Cleared Mar 17, 1997
ACUMED SUTURE WASHER
K965028 · HTN
Acu Med, Inc.
Orthopedic · 90d
Cleared Mar 17, 1997
SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT...
K965077 · DZE
Implant Innovations, Inc.
Dental · 90d
Cleared Mar 17, 1997
CARDIOBEEPER CB-12L
K965101 · DXH
Meridian Medical Technologies, Inc.
Cardiovascular · 87d
Cleared Mar 17, 1997
DGH MODEL 9000
K965127 · HQC
Dgh Technology, Inc.
Ophthalmic · 84d
Cleared Mar 17, 1997
LIBERTY ANTERIOR SPINAL SYSTEM
K965193 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 83d
Cleared Mar 17, 1997
RADX SYSTEM
K965203 · EHD
Electro Medical Systems, Inc.
Radiology · 81d
Cleared Mar 17, 1997
SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM
K970034 · ITX
Hewlett-Packard Co.
Radiology · 73d
Cleared Mar 17, 1997
AMICAS WEB/INTRANET IMAGE SERVER
K970064 · LMD
Autocyt Group, Inc.
Radiology · 69d
Cleared Mar 17, 1997
NEURO-TRAIN II (2)
K970155 · IPF
Sterne Equipment Co., Ltd.
Physical Medicine · 60d