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
166945–166968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 1980
LIPASE DETERMINATION
K800550 · CFG
The Dow Chemical Co.
Chemistry · 23d
Cleared Apr 02, 1980
KDA MICRO CHEMICAL ANALYZER
K800572 · JJE
American Monitor Corp.
Chemistry · 19d
Cleared Apr 02, 1980
PERCUTANEOUS CATHETER INTRODUCER
K800580 · DYB
Alva Medical, Inc.
Cardiovascular · 19d
Cleared Apr 02, 1980
NSI CREATININE KIT
K800583 · CGX
Nobel Scientific Industries, Inc.
Chemistry · 16d
Cleared Apr 02, 1980
NSI SODIUM/POTASSIUM KIT
K800584 · JGS
Nobel Scientific Industries, Inc.
Chemistry · 16d
Cleared Apr 02, 1980
NSI CHLORIDE REAGENT KIT
K800585 · JFS
Nobel Scientific Industries, Inc.
Chemistry · 16d
Cleared Apr 02, 1980
CONTOUROGRAPH M-500
K800591 · LDK
Bio-Tek Instruments, Inc.
Physical Medicine · 16d
Cleared Apr 02, 1980
SIRECUST 311S
K800593 · DPS
Siemens Corp.
Cardiovascular · 16d
Cleared Apr 02, 1980
REUSABLE HAND-TROL
K800597 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 16d
Cleared Apr 02, 1980
ANA LATEX SLIDE TEST
K800605 · DHC
Biologics Intl., Inc.
Microbiology · 16d
Cleared Apr 02, 1980
MEDTEK #411 PORTABLE B-P INSTR.
K800614 · DXN
Med-Tek Corp.
Cardiovascular · 15d
Cleared Apr 02, 1980
TYPE 4000 TRANSCUTANEOUS ELEC. STIM.
K800630 · GZJ
Frye Electronics, Inc.
Neurology · 13d
Cleared Apr 02, 1980
OXYMETER
K800631 · KLK
Dragerwerk AG
Anesthesiology · 13d
Cleared Apr 02, 1980
OHIO DISPOSABLE TRACHEAL TUBE
K800634 · BTR
Ohio Medical Products
Anesthesiology · 12d
Cleared Apr 02, 1980
MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM
K800650 · CBK
Hospal Medical Corp.
Anesthesiology · 9d
Cleared Apr 02, 1980
SURE FLOW TUBING
K800664 · BYX
B & F Medical Products, Inc.
Anesthesiology · 7d
Cleared Apr 02, 1980
FIBERGLASS CYLINDER BASES, #'S 65040-
K800665
B & F Medical Products, Inc.
Cardiovascular · 7d
Cleared Mar 25, 1980
SUSI II PACEMAKER SURVEILLANCE MONITOR
K792602 · DTC
Ela Medical, Inc.
Cardiovascular · 98d
Cleared Mar 25, 1980
AXIOM VESSEL LOOPS
K800015 · KDC
Axiom Medical, Inc.
General & Plastic Surgery · 81d
Cleared Mar 25, 1980
WATER JEL FIRE BLANKET
K800064 · FPY
Trilling Resources, Ltd.
General & Plastic Surgery · 74d
Cleared Mar 25, 1980
HMB-200
K800250 · IRO
Associated Mills, Inc.
Physical Medicine · 48d
Cleared Mar 25, 1980
CESIUM-137 AFTERLOADING SYSTEM /GYN.BRA.
K800320 · IWJ
Amersham Corp.
Radiology · 42d
Cleared Mar 25, 1980
MAGNESIUM REAGENT
K800327 · JGJ
Alta Diagnostics, Inc.
Chemistry · 42d
Cleared Mar 25, 1980
DVT PREVENTION SYS. MBE 22 PRESSURE U.
K800337 · JOW
Med-Bio Engineering, Inc.
Cardiovascular · 39d