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
97633–97656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1996
PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065
K954884 · IYO
Vingmed Sound, Inc.
Radiology · 218d
Cleared May 28, 1996
HIGH RISK GLOVES
K955241 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 195d
Cleared May 28, 1996
KODAK EC-L CASSETTE
K960834 · IYE
Eastman Kodak Company
Radiology · 89d
Cleared May 28, 1996
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
K961069 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 71d
Cleared May 28, 1996
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE...
K961248 · FFL
C.R. Bard, Inc.
Gastroenterology & Urology · 57d
Cleared May 28, 1996
FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS
K961291 · EIH
Dentsply Intl.
Dental · 54d
Cleared May 28, 1996
INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP
K961430 · GCJ
Innerdyne, Inc.
General & Plastic Surgery · 43d
Cleared May 28, 1996
AQ HYDROPHILIC STENT
K961446 · FAD
Cook Urological, Inc.
Gastroenterology & Urology · 42d
Cleared May 28, 1996
EMERALD STERILE GAUZE SPONGE
K961581 · EFQ
Emerald Medical, Inc.
General & Plastic Surgery · 34d
Cleared May 28, 1996
TELESCOPING PENEVAC (MODIFICATION)
K961616 · GEI
I.C Medical, Inc.
General & Plastic Surgery · 36d
Cleared May 28, 1996
MONOTUBE TUBE TO RING CLAMP
K961618 · JEC
Howmedica Corp.
Orthopedic · 32d
Cleared May 28, 1996
PARACENTESIS TRAYS
K961863 · LRO
Tri-Med, Inc.
General & Plastic Surgery · 14d
Cleared May 24, 1996
STENODOC
K946349 · IYO
Specs USA, Inc.
Radiology · 511d
Cleared May 24, 1996
TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION)
K954258 · LJT
Gerard Medical Enterprises, Inc.
General Hospital · 262d
Cleared May 24, 1996
DISETRONIC MULTIFUSE PUMP SYSTEM
K954826 · FRN
Disetronic Medical Systems
General Hospital · 217d
Cleared May 24, 1996
GREEN TEC-2100
K955236 · IWE
Medtec, Inc.
Radiology · 192d
Cleared May 24, 1996
ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03
K955633 · DIC
Diagnostic Chemicals , Ltd.
Toxicology · 165d
Cleared May 24, 1996
BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000
K955840 · IYO
Diagnostic Ultrasound Corp.
Radiology · 150d
Cleared May 24, 1996
EKTACHEM DT LDL CHOLESTEROL KIT
K955904 · MRR
Johnson & Johnson Clinical...
Chemistry · 147d
Cleared May 24, 1996
OPTI-MAX BODY DIAMETER W/5MM TOP W/EXTERNAL HEX, EXTERNALLY THREADED DENTAL...
K960022 · DZE
Opti-Max
Dental · 143d
Cleared May 24, 1996
BRANNON PEDI PORTSYRINGE
K960047 · FMF
James K. Brannon
General Hospital · 143d
Cleared May 24, 1996
BRANNON PORTSYRINGE
K960049 · FMF
James K. Brannon
General Hospital · 143d
Cleared May 24, 1996
POWDER FREE LATEX EXAMINATION GLOVE
K960467 · LYY
Biopro, Inc.
General Hospital · 115d
Cleared May 24, 1996
CD-CHEX + RBC
K960894 · GGL
Streck Laboratories, Inc.
Hematology · 80d