FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72745–72768 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2003
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
K030462 · KFM
Cobe Cardiovascular, Inc.
Cardiovascular · 22d
Cleared Mar 06, 2003
SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES
K030483 · LYZ
Emerald Medical, Inc.
General Hospital · 20d
Cleared Mar 06, 2003
SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES
K030484 · LYZ
Emerald Medical, Inc.
General Hospital · 20d
Cleared Mar 06, 2003
INTERA FAMILY
K030520 · LNH
Philips Medical Systems North America...
Radiology · 15d
Cleared Mar 05, 2003
DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
K021533 · FXX
Creative Contract (M) Sdn Bhd
General Hospital · 299d
Cleared Mar 05, 2003
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH...
K021539 · FXX
Creative Contract (M) Sdn Bhd
General Hospital · 299d
Cleared Mar 05, 2003
DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR
K021546 · FXX
Creative Contract (M) Sdn Bhd
General Hospital · 299d
Cleared Mar 05, 2003
FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR
K022412 · KDJ
Fresenius Medical Care North America
Gastroenterology & Urology · 224d
Cleared Mar 05, 2003
CIMOFLUOR
K023888 · EMA
Global Dental Products, Inc.
Dental · 104d
Cleared Mar 05, 2003
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065 · DTN
Gish Biomedical, Inc.
Cardiovascular · 86d
Cleared Mar 05, 2003
IVD CRYPTO/GIARDIA DFA
K024113 · MHI
Ivd Research, Inc.
Microbiology · 82d
Cleared Mar 05, 2003
SMEARCLEAR
K024198 · KJJ
Sybron Dental Specialties, Inc.
Dental · 75d
Cleared Mar 05, 2003
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
K030075 · LZA
Best Manufacturing...
General Hospital · 56d
Cleared Mar 05, 2003
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
K030449 · DTN
Terumo Corp.
Cardiovascular · 22d
Cleared Mar 05, 2003
3.0T TORSO PHASED ARRAY COIL
K030495 · MOS
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Mar 04, 2003
ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
K021878 · LPH
Eska America Corp.
Orthopedic · 270d
Cleared Mar 04, 2003
HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
K022917 · GXY
Home Care Technology Co., Ltd.
Neurology · 182d
Cleared Mar 04, 2003
SELF SEAL STERILIZATION POUCH
K023025 · FRG
Granton Medical , Ltd.
General Hospital · 174d
Cleared Mar 04, 2003
NUVASIVE MASH
K023319 · MQP
Nuvasive, Inc.
Orthopedic · 151d
Cleared Mar 04, 2003
ORIA CERVICAL PLATES
K023377 · KWQ
Ortho Tec, LLC
Orthopedic · 147d
Cleared Mar 04, 2003
STAIRFRIEND CURVED STAIRWAY CHAIRLIFT
K023852 · ILK
Services Industriels Savaria, Inc.
Physical Medicine · 105d
Cleared Mar 04, 2003
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K024015 · NLM
Alliance Medical Corp.
Gastroenterology & Urology · 90d
Cleared Mar 04, 2003
VIDAR BONE TRACK SYSTEM SOFTWARE
K024171 · JAK
Vidar Systems Corp.
Radiology · 76d
Cleared Mar 04, 2003
MIIG II BONE GRAFT SUBSTITUTE
K024336 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 67d