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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119185–119208 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 1991
MODEL 520A NOVAMETRIX PULSE OXIMETER
K913516 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 89d
Cleared Nov 01, 1991
K-SOL(TM)
K911587 · KDN
Alcon Laboratories
Gastroenterology & Urology · 206d
Cleared Nov 01, 1991
NORTEC CONNECTING TUBE SET
K911865 · GAZ
North American Sterilization &...
General Hospital · 189d
Cleared Nov 01, 1991
SMOKE/ODOR EVACUATOR #757
K912612 · FYD
Olsen Electrosurgical, Inc.
General Hospital · 142d
Cleared Nov 01, 1991
LASER ENDOSCOPE DISC DECOMPRESSION KITS
K913136 · LRO
Medical Laser, Inc.
General & Plastic Surgery · 108d
Cleared Nov 01, 1991
HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE
K913264 · LLZ
Mallinckrodt Group, Inc.
Radiology · 101d
Cleared Nov 01, 1991
BONE-TEMNO/STERNUM-TEMNO
K913306 · LWE
Proact, Ltd.
General Hospital · 99d
Cleared Nov 01, 1991
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321 · KGI
Hologic, Inc.
Radiology · 99d
Cleared Nov 01, 1991
40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE
K913325 · LNH
Resonex, Inc.
Radiology · 99d
Cleared Nov 01, 1991
MICRO-AIRE MODEL 2060
K913369 · GEY
Micro Surgical Instruments Corp.
General & Plastic Surgery · 95d
Cleared Nov 01, 1991
TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC
K913494 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 87d
Cleared Nov 01, 1991
TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC
K913495 · EPF
Telex Communications, Inc.
Ear, Nose, Throat · 87d
Cleared Nov 01, 1991
SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS
K913526 · FJK
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 85d
Cleared Nov 01, 1991
SURGI-SPRAY O.R. IRRIGATION SYSTEM
K913568 · FQH
Phoenix Surgical Products, Inc.
General Hospital · 84d
Cleared Nov 01, 1991
MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR
K913578 · IZO
Control-X, Inc.
Radiology · 81d
Cleared Nov 01, 1991
ENEMA KIT
K913620 · FCE
York County Blind Center
Gastroenterology & Urology · 80d
Cleared Nov 01, 1991
ENDOSTAT ELECTROSURGICAL UNIT
K913881 · KNS
Medical and Scientific Enterprises, Inc.
Gastroenterology & Urology · 64d
Cleared Nov 01, 1991
ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET
K913911 · DPJ
Roche Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Nov 01, 1991
DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY
K913950 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 58d
Cleared Nov 01, 1991
NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE
K913999 · GCJ
American Surgical Instruments Corp.
General & Plastic Surgery · 56d
Cleared Nov 01, 1991
MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)
K914019 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 53d
Cleared Nov 01, 1991
ER-1000 CATHERIZATION C-ARM SYSTEMS
K914348 · IYB
Shimadzu Medical Systems
Radiology · 35d
Cleared Nov 01, 1991
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
K914509 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD19
K901186 · GKZ
Sigma Chemical Co.
Hematology · 597d