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
152737–152760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1984
VENTREZYME T4U IMMUNOASSAY T4U
K841024 · CEE
Ventrex Laboratories, Inc.
Chemistry · 58d
Cleared May 09, 1984
CHARLES/MCINTYRE GIANT BREAK TABLE
K841115 · FQO
Surgi-Quip Inc.U
General & Plastic Surgery · 55d
Cleared May 09, 1984
MOBILE OPHTHALMIC OPERATING TABLE
K841116 · FWX
Surgi-Quip Inc.U
General & Plastic Surgery · 55d
Cleared May 09, 1984
STERILIZATION PROCESS INDICATOR
K841168 · JOJ
Parke-Davis Co.
General Hospital · 51d
Cleared May 09, 1984
ASTRA SYS INORGANIC PHOSPHORUS CHEM
K841181 · CEO
Beckman Instruments, Inc.
Chemistry · 50d
Cleared May 09, 1984
MULTIPLE CHEM. MODULE FOR ANALYSIS
K841182 · CHH
Beckman Instruments, Inc.
Chemistry · 50d
Cleared May 09, 1984
SPECTACLE INDIRECT OPHTHALMOSCOPE
K841292 · HLJ
Keller Instruments, Inc.
Ophthalmic · 41d
Cleared May 09, 1984
PANORAMIC LOUPES - VARIOUS
K841293 · HLT
Keller Instruments, Inc.
Ophthalmic · 41d
Cleared May 09, 1984
REPLACE-A-TIP RECHARG. LOW TEMP.
K841325 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 37d
Cleared May 09, 1984
REPLACE-A-TIP RECHARGEABLE HIGH TEMP
K841326 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 37d
Cleared May 09, 1984
CIVCO/SUPER SCAN
K841332 · IYO
CIVCO Medical Instruments Co., Inc.
Radiology · 37d
Cleared May 09, 1984
KOLLMANN URETHRAL DILATOR
K841386 · KOE
Imm Enterprises , Ltd.
Gastroenterology & Urology · 43d
Cleared May 09, 1984
WESTON RECTAL SNARE
K841387 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 43d
Cleared May 09, 1984
INTELECT 205 PORTABLE ULTRASOUND UNIT
K841445 · IMI
Chattanooga Group, Inc.
Physical Medicine · 33d
Cleared May 09, 1984
INTELECT 200 THERAPEUTIC ULTRASOUND
K841446 · IMI
Chattanooga Group, Inc.
Physical Medicine · 33d
Cleared May 09, 1984
INTELECT 210 PORTABLE ULTRASOUND
K841447 · IMI
Chattanooga Group, Inc.
Physical Medicine · 33d
Cleared May 09, 1984
UROLOGICAL KIT W/STERILE, WATER-FILL
K841485 · KOD
Medline Industries, Inc.
Gastroenterology & Urology · 29d
Cleared May 09, 1984
CONVAID - SPEECH AID
K841528 · ILQ
Convaid , Ltd.
Physical Medicine · 27d
Cleared May 09, 1984
MOBILIZATIOIN TABLE
K841594 · INQ
Chattanooga Group, Inc.
Physical Medicine · 21d
Cleared May 09, 1984
CONTINUOUS PASSIVE MOTION
K841674 · BXB
Chattanooga Group, Inc.
Physical Medicine · 16d
Cleared May 09, 1984
SPLIT SEAT POSITIONING CHAIR
K841691 · INN
Maddak, Inc.
Physical Medicine · 16d
Cleared May 09, 1984
PRONE STANDER
K841692
Maddak, Inc.
Physical Medicine · 16d
Cleared May 09, 1984
STANDING FRAME
K841693
Maddak, Inc.
Physical Medicine · 16d
Cleared May 09, 1984
HYDRO-THERO PAD
K841697 · IRT
Maddak, Inc.
Physical Medicine · 16d