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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
139537–139560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 26, 1987
SYVA Q-SPEC PHOTOMETER
K871307 · JJQ
Syva Co.
Chemistry · 55d
Cleared May 26, 1987
MODEL U-1000 WITH GESTATIONAL AGE CALCULATION
K871385 · HGM
Fukuda Denshi USA, Inc.
Obstetrics & Gynecology · 49d
Cleared May 26, 1987
AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT
K871505 · JLW
Micromedic Systems
Chemistry · 39d
Cleared May 26, 1987
KITS AND TRAYS FOR DIALYSIS USE
K871630 · FKG
Dove Medical Supplies
Gastroenterology & Urology · 29d
Cleared May 26, 1987
KESTREL CONTACT LENS CASE
K871714 · LPN
Applied Laboratories, Inc.
Ophthalmic · 22d
Cleared May 26, 1987
GLUCOSE STANDARD SOLUTION CALIBRATOR
K871758 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
MAGNESIUM STANDARD SOLUTION CALIBRATOR
K871762 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
NEFA STANDARD SOLUTION CALIBRATOR
K871763 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR
K871764 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR
K871765 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR
K871766 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
UREA N STANDARD SOLUTION CALIBRATOR
K871767 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
URIC ACID STANDARD SOLUTION CALIBRATOR
K871768 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)
K871782 · CKA
Biochemical Trade, Inc.
Chemistry · 20d