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
89737–89760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1998
TEMPORARY CARDIAC PACING WIRE
K980503 · LDF
Ethicon, Inc.
Cardiovascular · 60d
Cleared Apr 09, 1998
SORBASTACE
K965034 · QSY
Hemostace, LLC
General & Plastic Surgery · 478d
Cleared Apr 09, 1998
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND)
K970761 · LSR
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Apr 09, 1998
HUMAN LYME IGM WESTERN BLOT KIT
K970768 · LSR
Cambridge Diagnostics Ireland, Ltd.
Microbiology · 402d
Cleared Apr 09, 1998
ONE STEP MIDSTREAM HCG PREGNANCY TEST
K974059 · LCX
International Newtech Development, Inc.
Chemistry · 164d
Cleared Apr 09, 1998
MINISTRIP/ SERUM AND URINE COMBO HCG TEST
K974060 · JHI
International Newtech Development, Inc.
Chemistry · 164d
Cleared Apr 09, 1998
PERIACRYL
K974097 · EMA
Blacklock Medical Products, Inc.
Dental · 161d
Cleared Apr 09, 1998
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES
K980079 · GCJ
Lumenis, Inc.
General & Plastic Surgery · 90d
Cleared Apr 09, 1998
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K980081 · LZO
Johnson & Johnson Professionals, Inc.
Orthopedic · 90d
Cleared Apr 09, 1998
LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60
K980091 · ITX
Cosmaceutical Marketing, Inc.
Radiology · 90d
Cleared Apr 09, 1998
ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))
K980099 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 87d
Cleared Apr 09, 1998
OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
K980159 · EMA
Closure Medical Corp.
Dental · 83d
Cleared Apr 09, 1998
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)
K980235 · IZH
Kci New Technologies, Inc.
Radiology · 77d
Cleared Apr 09, 1998
BIODERM CALCIUM ALGINATE DRESSING
K980451 · KMF
Bioderm, Inc.
General & Plastic Surgery · 63d
Cleared Apr 09, 1998
KHT GUAM NEEDLE, ACUPUNCTURE NEEDLE
K980471 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 62d
Cleared Apr 09, 1998
KHT SOFT NEEDLE, ACUPUNCTURE NEEDLE
K980472 · MQX
American Institute of Koryo Hand Therapy
General Hospital · 62d
Cleared Apr 09, 1998
BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY
K980541 · LMD
Barco NV Display Systems
Radiology · 57d
Cleared Apr 09, 1998
MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER
K980617 · GDW
Urohealth Systems, Inc.
General & Plastic Surgery · 76d
Cleared Apr 09, 1998
VACUETTE HOLDEX
K980768 · FMI
Greiner Meditech, Inc.
General Hospital · 41d
Cleared Apr 08, 1998
ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)
K963703 · DPT
International Biophysics Corp.
Cardiovascular · 569d
Cleared Apr 08, 1998
BETTER-TUBING
K964205 · DWF
Circulatory Technology, Inc.
Cardiovascular · 537d
Cleared Apr 08, 1998
AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR...
K973697 · MUW
Airperm, Inc.
Ophthalmic · 194d
Cleared Apr 08, 1998
LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
K974302 · GNW
Light Diagnostics
Microbiology · 142d
Cleared Apr 08, 1998
GYNEX ENDOSPECULUM
K980237 · KNA
Gynex Corp.
Obstetrics & Gynecology · 75d