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
132985–133008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 07, 1989
DIFCO DIRECTOR INOCULATION SYSTEM
K890339 · LIE
Difco Laboratories, Inc.
Microbiology · 15d
Cleared Feb 07, 1989
MODIFIED D-DI-TEST KIT
K890399 · GHH
American Bioproducts Co.
Hematology · 14d
Cleared Feb 06, 1989
GLOVE, SURGICAL
K884425 · KGO
Med-Pak Corp.
General Hospital · 109d
Cleared Feb 06, 1989
AL-800PA PULSE OXIMETER MODULE
K884536 · DQA
Nihon Kohden America, Inc.
Anesthesiology · 101d
Cleared Feb 06, 1989
ARBO PINK H82P
K884775 · DRX
Arbo Medical, Inc.
Cardiovascular · 82d
Cleared Feb 06, 1989
MODEL 499 SSR ANALYSIS SYSTEM
K884887 · DSI
Del Mar Avionics
Cardiovascular · 76d
Cleared Feb 06, 1989
ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
K884895 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 76d
Cleared Feb 06, 1989
JEHLE CORONARY PERFUSION CATHETERS
K884946 · KRA
Pilling Co.
Cardiovascular · 70d
Cleared Feb 06, 1989
SUPREME TONING SYSTEMS
K885095 · BXB
Supreme Toning Systems
Physical Medicine · 59d
Cleared Feb 06, 1989
GRAFT GUARD
K885136 · LZM
Sorex Medical
General & Plastic Surgery · 53d
Cleared Feb 06, 1989
MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY
K885188 · DWF
Quinton, Inc.
Cardiovascular · 61d
Cleared Feb 06, 1989
MODEL 8700 PULSE OXIMETER
K890033 · DQA
Nonin Medical, Inc.
Anesthesiology · 33d
Cleared Feb 06, 1989
SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #749
K890059 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 31d
Cleared Feb 06, 1989
A10 ULTRASCOPE RECORDER
K890142 · DSF
Ems Medical, Inc.
Cardiovascular · 24d
Cleared Feb 06, 1989
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
K890191 · IWJ
Amersham Corp.
Radiology · 19d
Cleared Feb 03, 1989
THE BOOSTER
K860698 · LKY
Knapps Corp.
Gastroenterology & Urology · 1074d
Cleared Feb 03, 1989
STERILE & NON-STERILE SURGEONS GLOVES
K882200 · KGO
Taroko Ent., Ltd.
General Hospital · 263d
Cleared Feb 03, 1989
LATEX SURGICAL GLOVE (NON STERILE)
K883556 · KGO
Makintech Corp.
General Hospital · 168d
Cleared Feb 03, 1989
COONRAD III TOTAL ELBOW
K883665 · JDC
Zimmer, Inc.
Orthopedic · 161d
Cleared Feb 03, 1989
COULTER CLONE T3 MONOCLONAL ANTIBODY
K883710 · GKZ
Coulter Immunology
Hematology · 157d
Cleared Feb 03, 1989
COULTER CLONE T1 MONOCLONAL ANTIBODY
K883753 · GKZ
Coulter Immunology
Hematology · 154d
Cleared Feb 03, 1989
BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE
K883776 · LKI
Btc Corp.
Microbiology · 150d
Cleared Feb 03, 1989
RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER
K883845 · DXK
Phoenix Imaging
Cardiovascular · 144d
Cleared Feb 03, 1989
COULTER CLONE B4 MONOCLONAL ANTIBODY
K884020 · GKZ
Coulter Immunology
Hematology · 134d