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
146185–146208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1986
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
K852387 · ETD
Xomed, Inc.
Ear, Nose, Throat · 215d
Cleared Jan 06, 1986
ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M
K852947 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 179d
Cleared Jan 06, 1986
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE
K853641 · ETD
Xomed, Inc.
Ear, Nose, Throat · 125d
Cleared Jan 06, 1986
DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT
K854089 · JPA
Diatech, Inc.
Hematology · 91d
Cleared Jan 06, 1986
DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT
K854090 · JPA
Diatech, Inc.
Hematology · 91d
Cleared Jan 06, 1986
TUBING SYRING
K854699 · ECB
Almore Intl., Inc.
Dental · 46d
Cleared Jan 03, 1986
AKUFON THERAPEUTIC MASSAGER
K850495 · IRO
Jansson A/S
Physical Medicine · 329d
Cleared Jan 03, 1986
VITATRON M
K852034
Elmed, Inc.
Physical Medicine · 239d
Cleared Jan 03, 1986
SATALEC SEPTOSONIC SC 80/SC 120
K852527 · FLG
Spelna, Inc.
General Hospital · 203d
Cleared Jan 03, 1986
GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB
K852632 · CAI
Medicomp, Inc.
Anesthesiology · 197d
Cleared Jan 03, 1986
THERACUSHION
K853710 · ISA
General Physiotherapy, Inc.
Physical Medicine · 120d
Cleared Jan 03, 1986
MEDAR APM FORCE TRANSDUCER
K853849 · BXN
Medar Corp., Inc.
Anesthesiology · 109d
Cleared Jan 03, 1986
ASSERA PLATE IX:AG KIT
K854014 · GGP
American Bioproducts Co.
Hematology · 98d
Cleared Jan 03, 1986
ASSERACHROM PROTEIN C KIT
K854016 · JLA
American Bioproducts Co.
Hematology · 98d
Cleared Jan 03, 1986
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
K854081 · GQG
Boots-Celltech Diagnostics, Inc.
Microbiology · 88d
Cleared Jan 03, 1986
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR
K854212 · BZT
Respiratory Support Products, Inc.
Anesthesiology · 78d
Cleared Jan 03, 1986
OXYGEN CONCENTRATOR, MODEL BX-5000
K854374 · CAW
Healthdyne, Inc.
Anesthesiology · 65d
Cleared Jan 03, 1986
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
K854447 · GTZ
American Micro Scan
Microbiology · 59d
Cleared Jan 03, 1986
ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE
K854573 · CAI
Artec Environmental Monitoring Division
Anesthesiology · 50d
Cleared Jan 03, 1986
ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7
K854612 · LFK
Med-West, Inc.
Gastroenterology & Urology · 46d
Cleared Jan 03, 1986
ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE
K854632 · BTR
Respiratory Support Products, Inc.
Anesthesiology · 43d
Cleared Jan 03, 1986
ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA I&STATIONAR
K854635 · INQ
Electra Equipment , Ltd.
Physical Medicine · 45d
Cleared Jan 03, 1986
CHURCHHILL LANCET
K854760 · FMK
Churchill Corp.
General & Plastic Surgery · 37d
Cleared Jan 03, 1986
SETMA HYGIA BATH MODEL ST 7200
K854861 · ILJ
Setma, Inc.
Physical Medicine · 29d