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
133897–133920 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1988
QUIK-PACE II ELECTRODES
K883121 · DRO
Physio-Control Corp.
Cardiovascular · 56d
Cleared Sep 19, 1988
MODIFIED LASERFLO BLOOD PERFUSION MONITOR, BPM403A
K875179 · DPW
Tsi, Inc.
Cardiovascular · 277d
Cleared Sep 19, 1988
MODEL #1551 SWITCH CONTROL INTERFACE UNIT
K880360 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1552 ATTENDANT CONTROL OPTION
K880361 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1553 RECLINER INTERFACE
K880362 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1554 PNEUMATIC SWITCH
K880363 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1555 REMOTE JOYSTICK
K880364 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
MODEL #1556 HEAVY-DUTY JOYSTICK
K880365 · ITI
Invacare Corp.
Physical Medicine · 237d
Cleared Sep 19, 1988
ELECTROSTIMULATOR MODEL 808
K880426 · GZJ
Cornell Enterprises Co., Inc.
Neurology · 231d
Cleared Sep 19, 1988
PXI (PERSONAL X-RAY IMAGER) 512
K881993 · LLZ
Oklahoma Digital Technologies, Inc.
Radiology · 130d
Cleared Sep 19, 1988
MAMMO M
K882133 · IZH
Ziehm International, Inc.
Radiology · 122d
Cleared Sep 19, 1988
VARIAN CLINAC 1800S
K882326 · IYE
Varian Assoc., Inc.
Radiology · 105d
Cleared Sep 19, 1988
BARBITURATE ENZYME IMMUNOASSAY KIT
K882663 · DIS
General Diagnostics
Toxicology · 84d
Cleared Sep 19, 1988
MEVATRON, M 2 CLASS
K882729 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 75d
Cleared Sep 19, 1988
A.C.I. TRACH TIE
K882891 · CBH
Auxiliary Care, Inc.
Anesthesiology · 70d
Cleared Sep 19, 1988
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181 · CKA
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Sep 19, 1988
EMIT (R) HVA NEGATIVE URINE
K883210 · DIF
Syva Co.
Toxicology · 52d
Cleared Sep 19, 1988
ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY
K883395 · JJT
Quantimetrix Medical Industries
Chemistry · 39d
Cleared Sep 19, 1988
HOSPITAL BED CLOTHING CRADLE
K883463 · FNL
Commercial Products & Engineering Co.
General Hospital · 35d
Cleared Sep 19, 1988
COULTER VISCOMETER II
K883503 · JJL
Coulter Electronics, Inc.
Chemistry · 33d
Cleared Sep 19, 1988
EXCELVIEW ILLUMINATOR
K883702 · IXC
Excel Medical Products, Inc.
Radiology · 20d
Cleared Sep 16, 1988
BARO-GRAF 24
K881297 · DRS
Instromedix, Inc.
Cardiovascular · 172d
Cleared Sep 16, 1988
PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE
K882655 · DQO
Procedure Packs, Inc.
Cardiovascular · 79d
Cleared Sep 16, 1988
MRL OXIMETER
K882664 · DQA
Medical Research Laboratories, Inc.
Anesthesiology · 81d