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

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175,820 results
129361–129384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 1989
AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER
K895071 · IYO
Acoustic Imaging
Radiology · 62d
Cleared Oct 12, 1989
R2 PACE ADAPTOR CABLE, MODEL 196
K895728 · DRO
Darox Corp.
Cardiovascular · 17d
Cleared Oct 12, 1989
R2 PACE PAD, MODEL 480
K895729 · DRO
Darox Corp.
Cardiovascular · 17d
Cleared Oct 11, 1989
HUMIDI-FLEX TM
K885313 · BYD
Life Design Systems, Inc.
Anesthesiology · 286d
Cleared Oct 11, 1989
MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS
K892450 · KGX
Quinton, Inc.
General & Plastic Surgery · 184d
Cleared Oct 11, 1989
SURGEON'S GLOVES
K892495 · KGO
Care-Pro Industries, Inc.
General Hospital · 181d
Cleared Oct 11, 1989
SAFETY SURGEONS GLOVES
K892499 · KGO
Advance Rubber, Inc.
General Hospital · 180d
Cleared Oct 11, 1989
PNEUMOTHORAX KIT, MOTIFICATION
K892640 · JDL
Arrow Intl., Inc.
Orthopedic · 182d
Cleared Oct 11, 1989
STUART CD UNIVERSAL ROD CONNECTOR CLAMPS
K894702 · KWP
Bio-Medical Prosthetics
Orthopedic · 76d
Cleared Oct 11, 1989
HT-RES RTP SYSTEM
K894706 · IYE
Adac Laboratories
Radiology · 79d
Cleared Oct 11, 1989
CUSTOM IN-THE-CANAL (ITC) HEARING AID MODEL I54
K895140 · ESD
Oticon Corp.
Ear, Nose, Throat · 56d
Cleared Oct 10, 1989
OVERDENTURE ATTACHMENT
K891613 · DZE
Implant Innovations International, Inc.
Dental · 204d
Cleared Oct 10, 1989
GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM
K893537 · LBB
Greenleaf Medical Systems, Inc.
Neurology · 155d
Cleared Oct 10, 1989
HYDRAULIC IV POLE
K893597 · FOX
Arthro-Medic, Inc.
General Hospital · 154d
Cleared Oct 10, 1989
HYDRAULIC FOOT OPERATED STOOL
K893598 · GBB
Arthro-Medic, Inc.
General & Plastic Surgery · 154d
Cleared Oct 10, 1989
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
K894189 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 116d
Cleared Oct 10, 1989
CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL
K894472 · KWP
Buckman Co., Inc.
Orthopedic · 84d
Cleared Oct 10, 1989
AMMEL PATIENT EXAMINATION GLOVES
K894502 · LYY
Mauricio Menconi
General Hospital · 83d
Cleared Oct 10, 1989
GORE-TEX SURGICAL TAPE
K894580 · FTM
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 78d
Cleared Oct 10, 1989
GYNEGUIDE
K894591 · GEX
Marlo Surgical Technology
General & Plastic Surgery · 78d
Cleared Oct 10, 1989
PT DISTAL TIP CEMENT SPACER
K894708 · JDK
Osteonics Corp.
Orthopedic · 78d
Cleared Oct 10, 1989
CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3
K894943 · GGT
Amgen, Inc.
Hematology · 68d
Cleared Oct 10, 1989
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
K894977 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 64d
Cleared Oct 10, 1989
POW-IR TIP
K895073 · GEX
Living Technology, Inc.
General & Plastic Surgery · 57d