Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
76561–76584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 18, 2002
BACT/ALERT SA CULTURE BOTTLE
K020931 · MDB
bioMerieux, Inc.
Microbiology · 27d
Cleared Apr 17, 2002
KSEA FIBERSCOPE
K011793 · LYK
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 313d
Cleared Apr 17, 2002
COMPEX SPORT
K011880 · NGX
Compex S.A.
Physical Medicine · 306d
Cleared Apr 17, 2002
TAMPONADE UTERINE BALLOON CATHETER SET
K013597 · KNA
Cook Ob/Gyn
Obstetrics & Gynecology · 168d
Cleared Apr 17, 2002
OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
K013882 · JXM
OraSure Technologies, Inc.
Toxicology · 145d
Cleared Apr 17, 2002
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
K014274 · HKI
Nidek, Inc.
Ophthalmic · 111d
Cleared Apr 17, 2002
EMULATE FAST SET AND EMULATE REGULAR SET
K020242 · ELW
Cavex Holland BV
Dental · 84d
Cleared Apr 17, 2002
4 ALL (DW286A)
K020253 · EJH
Ivoclar Vivadent, Inc.
Dental · 83d
Cleared Apr 17, 2002
UTERINE INJECTOR
K020292 · LKF
Catheter Research, Inc.
Obstetrics & Gynecology · 79d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH...
K020319 · LON
Dade Behring, Inc.
Microbiology · 77d
Cleared Apr 17, 2002
MYALLERGYTEST SYSTEM
K020387 · DHB
Immunetech Corporation
Immunology · 71d
Cleared Apr 17, 2002
PULPDENT GLAZE
K020432 · EBF
Pulpdent Corporation
Dental · 68d
Cleared Apr 17, 2002
PULPDENT POST CEMENT
K020481 · EMA
Pulpdent Corporation
Dental · 63d
Cleared Apr 17, 2002
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE...
K020506 · LON
Dade Microscan, Inc.
Microbiology · 61d
Cleared Apr 17, 2002
BACT/ALERT FA CULTURE BOTTLE
K020813 · MDB
bioMerieux, Inc.
Microbiology · 35d
Cleared Apr 17, 2002
NXSTAGE THERAPY SYSTEM
K020858 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 30d
Cleared Apr 17, 2002
EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
K020864 · KRH
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Apr 17, 2002
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
K020890 · DQO
St Jude Medical
Cardiovascular · 29d
Cleared Apr 17, 2002
SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X
K020940 · GAW
Sutura, Inc.
General & Plastic Surgery · 26d
Cleared Apr 17, 2002
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · FRN
Smith & Nephew, Inc.
General Hospital · 23d
Cleared Apr 17, 2002
NICOLET ELECTROCAUTERY DETECTOR
K020955 · ETN
Nicolet Biomedical, Inc.
Ear, Nose, Throat · 23d
Cleared Apr 17, 2002
OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
K021049 · OWB
Ge Oec Medical Systems
Radiology · 16d
Cleared Apr 17, 2002
MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD
K021077 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 14d
Cleared Apr 17, 2002
TRULINE REINFORCED VALVED INFUSION CATHETER
K021139 · FOZ
Micro Therapeutics, Inc.
General Hospital · 8d