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
75865–75888 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 30, 2002
DIGI-PRO TENS MODEL WL-2203 AND WL-2205
K021359 · GZJ
Well-Life Healthcare, Inc.
Neurology · 90d
Cleared Apr 29, 2002
REPROCESSED GUIDEWIRES
K012556 · NML
Sterilmed, Inc.
Gastroenterology & Urology · 264d
Cleared Apr 29, 2002
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
K013471 · LNS
E.S.W.L. Products, Inc.
Gastroenterology & Urology · 193d
Cleared Apr 29, 2002
GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
K020208 · NBW
Bayer Group Diagnostics
Chemistry · 97d
Cleared Apr 29, 2002
CLEARVIEW WRIST FIXATOR
K020311 · KTT
Rigid FX Orthopedics, Incorporated
Orthopedic · 90d
Cleared Apr 29, 2002
QUANTA LITE CCP ELISA
K020414 · NHX
Inova Diagnostics, Inc.
Immunology · 81d
Cleared Apr 29, 2002
EVANS SUB-Q, MODEL MC4206
K020530 · FPA
Evans Medical, Inc.
General Hospital · 69d
Cleared Apr 29, 2002
ETEST ERTAPENEM
K020748 · JWY
Ab Biodisk
Microbiology · 53d
Cleared Apr 29, 2002
CALIBRATING MATERIAL, CAL-PAK, BUFFERS
K020894 · JIT
Mission Diagnostics
Chemistry · 41d
Cleared Apr 29, 2002
MID LABS AUTONOMOUS VIT ENHANCER (AVE)
K020911 · HQE
Medical Instrument Development...
Ophthalmic · 40d
Cleared Apr 29, 2002
BUSSE UMBILICAL CORD CLAMP CUTTER
K021055 · HFW
Busse Hospital Disposables, Inc.
Obstetrics & Gynecology · 28d
Cleared Apr 29, 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
K021155 · JJW
Medical Analysis Systems, Inc.
Chemistry · 19d
Cleared Apr 26, 2002
CRYOPEN AND ACCESSORIES
K012214 · GEH
Cimex Biotech, LLC
General & Plastic Surgery · 284d
Cleared Apr 26, 2002
MICROJET CRONO
K013234 · FRN
Cane S.R.L.
General Hospital · 211d
Cleared Apr 26, 2002
MICROJET MODEL # CD4 AND CD4/20
K013776 · FRN
Cane S.R.I.
General Hospital · 164d
Cleared Apr 26, 2002
MALE LATEX CONDOM WITH RIBBED SURFACE
K020272 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 88d
Cleared Apr 26, 2002
LAP DISC 120 X 120MM X 2CM #LD111
K020307 · GCJ
Hakko Shoji Co., Ltd.
General & Plastic Surgery · 87d
Cleared Apr 26, 2002
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
K020392 · LPL
CooperVision, Inc.
Ophthalmic · 79d
Cleared Apr 26, 2002
FUSION 7D
K020546 · LLZ
Mirada Solutions , Ltd.
Radiology · 66d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
K020556 · JWY
Dade Microscan, Inc.
Microbiology · 65d
Cleared Apr 26, 2002
GC FUJI ORTHO BAND PASTE PAK
K020578 · DYH
GC America, Inc.
Dental · 64d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
K020626 · LTT
Dade Microscan, Inc.
Microbiology · 59d
Cleared Apr 26, 2002
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
K020690 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 53d
Cleared Apr 26, 2002
SIIS#1 TISSUE SUSPENSION SYSTEM
K020705 · OTN
Tag Medical Products
Gastroenterology & Urology · 53d