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
148417–148440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 1985
THUMPER CARDIOPULMONARY RESUSCITATOR 1005
K851139 · DRM
Michigan Instruments, Inc.
Cardiovascular · 55d
Cleared May 15, 1985
ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY
K851245 · BZE
Applinc
Anesthesiology · 49d
Cleared May 15, 1985
OHMEDA MODEL 0001/0003 RECORDER
K851274 · DSF
Ohmeda Medical
Cardiovascular · 44d
Cleared May 15, 1985
ACTION PAC
K851276 · LDQ
South Mountain Medical
General & Plastic Surgery · 44d
Cleared May 15, 1985
QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
K851302 · DRG
Quinton, Inc.
Cardiovascular · 44d
Cleared May 15, 1985
502 RESUSCITATORY INHALATOR VALVE
K851337 · BTL
Life Support Products, Inc.
Anesthesiology · 42d
Cleared May 15, 1985
ANTINUCLEAR ANTIBODY TEST KIT
K851369 · DHN
Modern Diagnostics, Inc.
Immunology · 40d
Cleared May 15, 1985
SANDER'S MASKCPAP BY RESPIRONICS
K851396 · BYE
Respironics, Inc.
Anesthesiology · 36d
Cleared May 15, 1985
CRCM-30 MEDIUM PRODUCT NO. C5030
K851604 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
SWIN'S S-77 MEDIUM, PRODUCTS S2513
K851605 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
D-PBS, PRODUCTS NO. D5652
K851606 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
MCDB 151 MEDIUM, PRODUCT NO. M6645
K851607 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
SFRE199-1 MEDIUM PRODUCT NO. S 2013
K851608 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
SFRE 199-2 MEDIUM, PRODUCTS NO. S2138
K851609 · KIT
Sigma Chemical Co.
Pathology · 29d
Cleared May 15, 1985
MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &
K851737 · KIT
Sigma
Hematology · 20d
Cleared May 15, 1985
MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &
K851738 · KIT
Sigma
Hematology · 20d
Cleared May 14, 1985
NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA
K844578 · FPO
Engineering Dynamics Corp.
Radiology · 172d
Cleared May 14, 1985
FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND
K850198 · IYB
Summit Industries, Inc.
Radiology · 116d
Cleared May 14, 1985
CRONEX KEVLAR CASSETTE
K850415 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 99d
Cleared May 14, 1985
SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT
K850640 · IMI
Fluidotherapy Corp.
Physical Medicine · 84d
Cleared May 14, 1985
DIGITAL GRIP/PINCH STRENGTH METOR
K850697 · LBB
Chattanooga Group, Inc.
Neurology · 82d
Cleared May 14, 1985
OSTER MASSAGE WAND STICK MASSAGER 295-07
K850771 · ISA
Daito Electric Machine Industries...
Physical Medicine · 78d
Cleared May 14, 1985
ALWAYS SUPER MAXIPAD-SCENTED
K850939 · HHL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 68d
Cleared May 14, 1985
ALWAYS SUPER MAXIPAD-UNSCENTED
K850940 · HHD
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 68d