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
83641–83664 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 2000
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR...
K994006 · GJS
Avocet Medical, Inc.
Hematology · 71d
Cleared Feb 03, 2000
EXTENDED STRAIGHT ATTACHMENT
K994024 · EGS
Team Technologies, Inc.
Dental · 69d
Cleared Feb 03, 2000
GLORY
K994127 · INI
Pillar Technology, Inc.
Physical Medicine · 58d
Cleared Feb 03, 2000
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
K994136 · LYZ
Shanghai Champion Plastic Products...
General Hospital · 58d
Cleared Feb 03, 2000
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
K994168 · JIS
Beckman Coulter, Inc.
Chemistry · 55d
Cleared Feb 03, 2000
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
K994169 · JIS
Beckman Coulter, Inc.
Chemistry · 55d
Cleared Feb 03, 2000
ADVANTAGE HCG TEST (URINE/SERUM)
K994227 · JHI
Advantage Diagnostics Corp.
Chemistry · 50d
Cleared Feb 03, 2000
SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
K994256 · GCJ
A & A Medical, Inc.
General & Plastic Surgery · 48d
Cleared Feb 03, 2000
ARABESK TOP
K994268 · EBF
Voco GmbH
Dental · 48d
Cleared Feb 03, 2000
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
K994338 · DHR
Cogent Diagnotics , Ltd.
Immunology · 42d
Cleared Feb 03, 2000
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
K994415 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 36d
Cleared Feb 03, 2000
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K994416 · LYY
Flexitech Sdn. Bhd.
General Hospital · 36d
Cleared Feb 02, 2000
QUINN'S SPERM WASHING MEDIUM
K991379 · MQL
Advanced Reproductive Technologies
Obstetrics & Gynecology · 287d
Cleared Feb 02, 2000
HYALURONIDASE, 80 U/ML
K991393 · MQL
Sage Biopharma
Obstetrics & Gynecology · 287d
Cleared Feb 02, 2000
SNAP MODEL 5
K992322 · MNR
Snap Laboratories, LLC
Anesthesiology · 205d
Cleared Feb 02, 2000
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
K992787 · HQD
Specialty Ultravision, Inc.
Ophthalmic · 167d
Cleared Feb 02, 2000
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
K993580 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 103d
Cleared Feb 02, 2000
SUPER TISSUE
K993742 · IYE
I.Z.I. Corp.
Radiology · 90d
Cleared Feb 02, 2000
PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV...
K993750 · LLZ
Problem Solving Concepts, Inc.
Radiology · 89d
Cleared Feb 02, 2000
COROMETRICS MODEL 173 FETAL MONITOR
K993751 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 89d
Cleared Feb 02, 2000
SIMPLEX CONDOMS, LATEX CONDOMS-FLAVORED AND LUBRICATED
K993779 · HIS
P.T. Vonix Latexindo Condom (Rubber)...
Obstetrics & Gynecology · 86d
Cleared Feb 02, 2000
SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
K993781 · HIS
P.T. Vonix Latexindo Condom (Rubber)...
Obstetrics & Gynecology · 86d
Cleared Feb 02, 2000
SIMPLEX CONDOMS, LATEX CONDOMS-WITH SPERMICIDAL LUBRICANT (NONOXYNOL-9)
K993782 · HIS
P.T. Vonix Latexindo Condom (Rubber)...
Obstetrics & Gynecology · 86d
Cleared Feb 02, 2000
RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY
K993786 · BTR
Rusch Intl.
Anesthesiology · 86d