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
163249–163272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1981
REAGENT SET TRIGLYCERIDES
K811553 · CHI
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Jun 18, 1981
TSH-P.E.G.
K811558 · JLW
Nuclear Diagnostics, Inc.
Chemistry · 16d
Cleared Jun 18, 1981
AUTOMATED PHYSIOLOGIC PROFILE MONITOR
K811560 · DXG
Life Sciences Manufacturing, Inc.
Cardiovascular · 16d
Cleared Jun 18, 1981
NERVE STIMULATOR MODEL AA 1050
K811614 · BXN
Anesthesia Assoc., Inc.
Anesthesiology · 10d
Cleared Jun 17, 1981
I.V. PLASTIC BAG
K811233 · KPE
Medi-Plast Intl., Inc.
General Hospital · 44d
Cleared Jun 16, 1981
CHEMATIC BICARBONATE DIALYSATE SYSTEM
K810605 · FKR
Trimedyne, Inc.
Gastroenterology & Urology · 102d
Cleared Jun 16, 1981
CERAVITAL CERAMIC OSSICULAR REPL. PROS.
K810707 · ETA
Xomed, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 16, 1981
#325 PROGRAMMABLE CARD. PULSE GENERATOR
K810884 · DXY
Cook Pacemaker Corp.
Cardiovascular · 76d
Cleared Jun 16, 1981
#326 PROGRAMMABLE CARD. PULSE GENERATOR
K810885 · DXY
Cook Pacemaker Corp.
Cardiovascular · 76d
Cleared Jun 16, 1981
BACILLUM PUMILUS SPORE STRIPS
K810930 · FRC
Oxoid U.S.A., Inc.
General Hospital · 71d
Cleared Jun 16, 1981
RIESS-LUHR
K811113 · DZA
Allomedic
Dental · 54d
Cleared Jun 16, 1981
PNEUMATIC DENTAL SCALER
K811145 · ELC
Innovate, Inc.
Dental · 50d
Cleared Jun 16, 1981
COHERENT FLOUROTRON MASTER
K811153 · HJO
Lumenis, Inc.
Chemistry · 50d
Cleared Jun 16, 1981
VICON
K811172 · LXJ
Oxford Medilog, Inc.
Physical Medicine · 49d
Cleared Jun 16, 1981
JACOB WIRZ TRANSFIXATION PIN
K811209 · ELS
Colmed, Ltd.
Dental · 46d
Cleared Jun 16, 1981
YOSHIDA AP 100
K811211 · EGY
Kaycor Intl., Ltd.
Radiology · 43d
Cleared Jun 16, 1981
MAGNETIC RETENTION UNIT
K811237 · ECG
Universiti Malaya
Dental · 43d
Cleared Jun 16, 1981
SUR-FIT LOOP OSTOMY O.R. SET
K811240 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 43d
Cleared Jun 16, 1981
GLASS VIALS
K811269 · KPE
Medi-Plast Intl., Inc.
General Hospital · 42d
Cleared Jun 16, 1981
HEARING AID MODEL E1-P
K811285 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 16, 1981
HEARING AID MODEL E1-PL
K811286 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 16, 1981
ALTRACLUDE
K811303 · KDC
R&H Medical, Inc.
General & Plastic Surgery · 36d
Cleared Jun 16, 1981
BEHIND-THE-EAR HEARING AID
K811344 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Jun 16, 1981
COLTENE DRS DENTAL RESTORATIVE SYSTEM
K811363 · EBF
Coltene, Inc.
Dental · 33d