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
155017–155040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1983
ROTAGYM
K832940 · ISD
I-Rep, Inc.
Physical Medicine · 70d
Cleared Nov 07, 1983
TOTAL & DIRECT BILIRUBIN PROCEDURES
K832942 · CIG
Sandare Chemical Co., Inc.
Chemistry · 69d
Cleared Nov 07, 1983
STIFNICK IMMOBILIZING COLLAR
K832990 · IQK
Laerdal California, Inc.
Physical Medicine · 67d
Cleared Nov 07, 1983
INFUSION SET-52-05-1 20 DROPS-MI VOL
K833033 · FPA
Y
General Hospital · 61d
Cleared Nov 07, 1983
UNIVERSAL VENTED & NON/VOLUME INFUS-
K833034 · FPA
Y
General Hospital · 61d
Cleared Nov 07, 1983
FLOW-PAC SODIUM REAGENT SET
K833036 · JGS
American Research Products Co.
Chemistry · 61d
Cleared Nov 07, 1983
C-FLEX PENROSE DRAINAGE TUBE
K833061 · FFA
Concept, Inc.
Gastroenterology & Urology · 59d
Cleared Nov 07, 1983
TDX GLUCOSE
K833069 · CGA
Abbott Laboratories
Toxicology · 60d
Cleared Nov 07, 1983
CASTLE TEC-TEST S.M.A.R.T. PACK
K833074 · JOJ
Castle Co.
General Hospital · 59d
Cleared Nov 07, 1983
SPIRIT CHEMISTRY SYSTEM
K833116 · JJE
Baker Instructions Corp.
Chemistry · 55d
Cleared Nov 07, 1983
FITNESS
K833249 · ION
Fitness Equipment Co., Inc.
Physical Medicine · 45d
Cleared Nov 07, 1983
BRUCELLA AGAR MODIFIED
K833299 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 46d
Cleared Nov 07, 1983
SABOURAUD BHI AGAR
K833300 · JSC
Acumedia Manufacturers, Inc.
Microbiology · 46d
Cleared Nov 07, 1983
AUTO-LANCET
K833344 · FMK
Palco Laboratories, Inc.
General & Plastic Surgery · 41d
Cleared Nov 07, 1983
MONOSPHERICAL RESURFACING GLENOID PROS
K833409 · KWT
Howmedica Corp.
Orthopedic · 38d
Cleared Nov 07, 1983
MONOSPHERICAL GLENOID PROSTH. KEEL
K833410 · KWS
Howmedica Corp.
Orthopedic · 38d
Cleared Nov 07, 1983
PACEMAKER EVALUATION MODULE-330
K833470 · DPS
Marquette Electronics, Inc.
Cardiovascular · 32d
Cleared Nov 07, 1983
PREPARED MACCONKEY AGAR
K833508 · JSI
Lavco Laboratory, Inc.
Microbiology · 27d
Cleared Nov 04, 1983
SHOT GUN KIT FOR CK-MB
K831391 · JHT
Serapine Corp.
Chemistry · 189d
Cleared Nov 03, 1983
PORTABLE DEFIBRILLATOR MONITOR 74DRK
K831696 · LDD
Honeywell, Inc.
Cardiovascular · 162d
Cleared Nov 03, 1983
ARF 850 E
K831877 · CBK
W.E. Leder Enterprises, Inc.
Anesthesiology · 143d
Cleared Nov 03, 1983
SURGICAL DRILL-ELECTRIC-HANDPIECE
K831946 · ERL
Entronics
Ear, Nose, Throat · 140d
Cleared Nov 03, 1983
THERMAL DILUTION CATHETER
K832324 · DYG
Catheter Corp. of America
Cardiovascular · 111d
Cleared Nov 03, 1983
SILICONE SOFT-PAK EPISTAXIS CATHETER
K832476 · ENW
Axiom Medical, Inc.
Ear, Nose, Throat · 100d