FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131569–131592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1989
GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
K890588 · HGX
Healthteam
Obstetrics & Gynecology · 99d
Cleared May 16, 1989
GRIESHABER VISCOELASTIC INJECTION SYSTEM
K890783 · FRN
Grieshaber & Co.
General Hospital · 90d
Cleared May 16, 1989
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K890919 · LZU
Eagle Vision, Inc.
Ophthalmic · 82d
Cleared May 16, 1989
TRANSESOPHAGEAL TRANSDUCER PEF-511SA
K890969 · IYO
Toshiba Medical Systems
Radiology · 78d
Cleared May 16, 1989
INTRAVASCULAR ADMINISTRATION SET MODEL 60040
K891009 · FPK
3M Company
General Hospital · 77d
Cleared May 16, 1989
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
K891309 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 67d
Cleared May 16, 1989
CVIS ULTRA-SCAN ONE IMAGING SYSTEM
K891386 · IYO
Cardiovascular Imaging Systems, Inc.
Radiology · 68d
Cleared May 16, 1989
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482 · KWL
Depuy, Inc.
Orthopedic · 60d
Cleared May 16, 1989
GDS ENZYMATIC THEOPHYLLINE REAGENT
K891761 · LCY
Gds Diagnostics
Chemistry · 53d
Cleared May 16, 1989
TDX BARBITURATES SERUM
K892650 · DIS
Abbott Laboratories
Chemistry · 34d
Cleared May 16, 1989
ACA VANCOMYCIN CALIBRATOR
K892901 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared May 15, 1989
HARBORIN CENTRAL VENOUS CATHETER
K884628 · DQR
Harbor Medical Devices, Inc.
Cardiovascular · 189d
Cleared May 15, 1989
A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL
K885348 · DQO
Mallinckroot, Inc.
Cardiovascular · 138d
Cleared May 15, 1989
VZV MICROASSAY
K890642 · LFY
Diamedix Corp.
Microbiology · 96d
Cleared May 15, 1989
ACCU-BEAM YAG FIBER
K890922 · GEX
Tti Medical
General & Plastic Surgery · 80d
Cleared May 15, 1989
ORTHOPAEDIC STAPLES
K890962 · JDR
Ortho Spectrum, Inc.
Orthopedic · 77d
Cleared May 15, 1989
COHN TARGETEER
K891903 · LXH
Orthopedic Systems, Inc.
Orthopedic · 49d
Cleared May 15, 1989
SAFE-T-FACE DISPOSABLE FACE SHIELD
K892451 · FXX
Barry S. Smith Co.
General Hospital · 35d
Cleared May 15, 1989
ELECTROSURGICAL PENCIL
K892502 · GEI
Yuntek International, Inc.
General & Plastic Surgery · 34d
Cleared May 15, 1989
ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA
K892887 · FIQ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 25d
Cleared May 12, 1989
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K884557 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 193d
Cleared May 12, 1989
LATEX DECONTAMINATION/PROCEDURE GLOVES (NON-STER)
K890440 · LYY
Tomarc (M) Sdn Bhd
General Hospital · 105d
Cleared May 12, 1989
LANGS EXAM GLOVE
K890776 · LYY
Langs Intl., Inc.
General Hospital · 86d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES
K891195 · LYY
Nbs Maronix Rubber Co. , Ltd.
General Hospital · 67d