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
140137–140160 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 26, 1987
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
K871811 · CIC
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT
K871820 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT
K871821 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY
K871822 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC TIBIAL POSITIONER
K871823 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM
K871824 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
BIOMEK 1000C AUTOMATED LABORATORY WORK STATION
K871838 · JJG
Beckman Instruments, Inc.
Chemistry · 14d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT
K871839 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 14d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC ANKLE POSITIONER
K871840 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 14d
Cleared May 26, 1987
SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM
K871855 · JSH
Gibco Laboratories Life Technologies,...
Microbiology · 13d