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
112009–112032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1993
FREEDOM OXIMETER/EEG DIGITAL INTERFACE
K924752 · DQA
Pro-Tech, Inc.
Anesthesiology · 352d
Cleared Sep 10, 1993
PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
K930606 · GYK
Pudenz-Schulte Medical Research Corp.
Neurology · 217d
Cleared Sep 10, 1993
HCG MIDSTREAM PREGNANCY TEST
K931997 · LCX
Mizuho USA, Inc.
Chemistry · 140d
Cleared Sep 10, 1993
VIDAS DIGOXIN (DIG)
K932250 · KXT
Biomerieux Vitek, Inc.
General & Plastic Surgery · 123d
Cleared Sep 10, 1993
MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION
K932743 · KGX
Scott Health Care
General & Plastic Surgery · 94d
Cleared Sep 10, 1993
GUIDING CATHETER HEMOSTASIS VALVE CAP
K933033 · DQY
Arrow Intl., Inc.
Cardiovascular · 80d
Cleared Sep 10, 1993
AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS
K933076 · GCJ
Aesculap, Inc.
General & Plastic Surgery · 79d
Cleared Sep 10, 1993
DISPOSABLE GRASPING FORCEP
K933244 · GWG
Neuro Navigational Corp.
Neurology · 70d
Cleared Sep 10, 1993
REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE
K933557 · LAS
Consolidated Technologies, Inc.
Toxicology · 51d
Cleared Sep 09, 1993
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
K915547 · KFM
3M Health Care, Sarns
Cardiovascular · 638d
Cleared Sep 09, 1993
RETRACTION INSTRUMENT
K921103 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 549d
Cleared Sep 09, 1993
BREMER IMAGING TONGS-MRI MODEL
K924606 · HAX
Bremer Medical, Inc.
Neurology · 363d
Cleared Sep 09, 1993
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K925641 · HJO
Carl Zeiss, Inc.
Ophthalmic · 304d
Cleared Sep 09, 1993
PATIENT EXAMINATION GLOVES
K926318 · LYY
I Ching Ent., Inc.
General Hospital · 268d
Cleared Sep 09, 1993
STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE
K926512 · HQC
Storz
Ophthalmic · 253d
Cleared Sep 09, 1993
GORE-TEX(TM) DUAL MESH
K926565 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 252d
Cleared Sep 09, 1993
AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT
K930006 · JLW
Bio-Chem Laboratory Systems, Inc.
Chemistry · 248d
Cleared Sep 09, 1993
STRYKER MPS ACUTE CARE BED
K931482 · FNL
Stryker Corp.
General Hospital · 169d
Cleared Sep 09, 1993
ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE
K931867 · EBF
Ultradent Products, Inc.
Dental · 148d
Cleared Sep 09, 1993
FISK ARM SUPPORT
K931876 · FWW
Vvortex International Corp.
General & Plastic Surgery · 148d
Cleared Sep 09, 1993
DRIGEL MULTIFUNCTION ELECTRODE
K931885 · GEI
Physiometrix, Inc.
General & Plastic Surgery · 147d
Cleared Sep 09, 1993
FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATE
K932260 · FPO
Ferno
General Hospital · 142d
Cleared Sep 09, 1993
FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT
K932417 · FPL
Ferno-Washington, Inc.
General Hospital · 114d
Cleared Sep 09, 1993
PULPDENT MALEIC ACID ETCHANTS
K932792 · EBF
Pulpdent Corp.
Dental · 92d