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.

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

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175,820 results
140113–140136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1987
SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP
K870842 · HTP
Warsaw Orthopedic, Inc.
Orthopedic · 85d
Cleared May 27, 1987
SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA
K870843 · HWT
Warsaw Orthopedic, Inc.
Orthopedic · 85d
Cleared May 27, 1987
IV START KIT
K871281 · LRS
The Jarid Group, Inc.
General & Plastic Surgery · 57d
Cleared May 27, 1987
ADVANCED MEDICAL SYSTEMS, KIT
K871322 · LRO
The Jarid Group, Inc.
General & Plastic Surgery · 54d
Cleared May 27, 1987
MODIFIED PROFILE HIP PMMA CEMENT SPACER
K871510 · JDI
Depuy, Inc.
Orthopedic · 42d
Cleared May 27, 1987
CARERITE BIOPACK GINGIVAL RETRACTION CORD
K871736 · JES
Cost Rite Health Products, Inc.
Dental · 22d
Cleared May 27, 1987
CREATININE STANDARD SOLUTION CALIBRATOR
K871756 · JIT
Wako Chemicals USA, Inc.
Chemistry · 22d
Cleared May 27, 1987
TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI
K871784 · KMT
Colgate-Hoyt Laboratories
Dental · 21d
Cleared May 27, 1987
COMPOSITE RESTORATIVE CARRIER
K871909 · EIY
Dentsply Intl.
Dental · 9d
Cleared May 26, 1987
GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA
K864282 · CGA
Medical Device Consultants, Inc.
Chemistry · 208d
Cleared May 26, 1987
SKIN GRAFT PRESERVATION MEDIUM (TISSUE)
K870451 · KIT
Bioclinical Laboratory Services, Inc.
Pathology · 112d
Cleared May 26, 1987
ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
K870572 · JOL
Arrow Intl., Inc.
General Hospital · 105d
Cleared May 26, 1987
NOILES TOTAL KNEE PROSTHESIS
K870730 · JWH
Joint Medical Products Corp.
Orthopedic · 90d
Cleared May 26, 1987
COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.
K870733 · GQN
Enzo Biochem, Inc.
Microbiology · 90d
Cleared May 26, 1987
MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE
K870837 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 89d
Cleared May 26, 1987
MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE
K870838 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 89d
Cleared May 26, 1987
MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT
K870904 · JLW
Micromedic Systems
Chemistry · 82d
Cleared May 26, 1987
MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT
K870970 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 77d
Cleared May 26, 1987
MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT
K870971 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 77d
Cleared May 26, 1987
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
K870987 · JHX
Ciba Corning Diagnostics Corp.
Chemistry · 76d
Cleared May 26, 1987
TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS
K870998 · JJC
Technicon Instruments Corp.
Chemistry · 76d
Cleared May 26, 1987
MICROMEDIC NEONATAL T4 KIT
K871008 · CDX
Micromedic Systems
Chemistry · 74d
Cleared May 26, 1987
ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8
K871150 · JIT
Beckman Instruments, Inc.
Chemistry · 64d
Cleared May 26, 1987
BED PATIENT PRESENCE MONITOR
K871203 · KMI
Human Technologies, Inc.
General Hospital · 62d