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
106537–106560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1994
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT
K943754 · JJY
Bionostics, Inc.
Chemistry · 43d
Cleared Sep 14, 1994
PORTLAND TROCARS
K943786 · GCJ
Mikroland Micromecanique
General & Plastic Surgery · 42d
Cleared Sep 14, 1994
SPECTACLE FRAMES
K943792 · HQZ
Kt Optique, Inc.
Ophthalmic · 42d
Cleared Sep 14, 1994
NIL
K943963 · HQY
Max-Vision (H.K.)Limited
Ophthalmic · 30d
Cleared Sep 14, 1994
MIRAGE EYEWEAR INC.
K944026 · HQY
Mirage Eyewear, Inc.
Ophthalmic · 28d
Cleared Sep 14, 1994
VIP PLUS PERCUTANEOUS INTRODUCER
K944107 · DYB
Medamicus, Inc.
Cardiovascular · 22d
Cleared Sep 14, 1994
NIL
K944108 · HQY
Micron Metal & Plastic Manufactory Co.
Ophthalmic · 22d
Cleared Sep 14, 1994
NIL
K944109 · HQY
Keep Top Intl., Ltd.
Ophthalmic · 22d
Cleared Sep 13, 1994
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
K940231 · DSP
Datascope Corp.
Cardiovascular · 238d
Cleared Sep 13, 1994
INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPES
K940731 · GCJ
Innervision, Inc.
General & Plastic Surgery · 207d
Cleared Sep 13, 1994
ASLAN DUAL ACTION JAWS GRASPING FORCEPS
K944082 · GCJ
Aslan Medical Technologies, Ltd.
General & Plastic Surgery · 22d
Cleared Sep 13, 1994
GABRIS LAPAROSCOPIC SURGICAL KITS
K944104 · FBQ
Gabris Surgical Corp.
General & Plastic Surgery · 21d
Cleared Sep 13, 1994
DAB WELDLESS WHEELCHAIR
K944122 · IOR
Da Intl. , Ltd.
Physical Medicine · 21d
Cleared Sep 13, 1994
DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME
K944194 · BYD
Med-Tek Innovations, Inc.
Anesthesiology · 15d
Cleared Sep 12, 1994
HEMODIALYSIS BATH
K922990 · KPO
Medi-Tech, Inc.
Gastroenterology & Urology · 812d
Cleared Sep 12, 1994
TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS
K933108 · LZO
Landos, Inc.
Orthopedic · 444d
Cleared Sep 12, 1994
KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II...
K935279 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 313d
Cleared Sep 12, 1994
HAIG NAIL
K940736 · JDS
Howmedica Corp.
Orthopedic · 207d
Cleared Sep 12, 1994
PASSPORT
K941853 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 151d
Cleared Sep 12, 1994
TRANSPARENT DRESSING
K943111 · MGP
Acutek Adhesive Specialties, Inc.
General & Plastic Surgery · 77d
Cleared Sep 12, 1994
GC SURFLEX F
K943388 · ELW
GC America, Inc.
Dental · 61d
Cleared Sep 12, 1994
LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT
K943989 · HFO
Gabris Surgical Corp.
Obstetrics & Gynecology · 27d
Cleared Sep 12, 1994
LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
K944103 · GCJ
Gabris Surgical Corp.
General & Plastic Surgery · 20d
Cleared Sep 09, 1994
SBS MODEL 1615
K924565 · CAW
Stand-By-Systems, Inc.
Anesthesiology · 730d