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
141817–141840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1986
SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES
K864175 · EFQ
Fraass Survival Systems, Inc.
General & Plastic Surgery · 12d
Cleared Nov 05, 1986
INTEGRA, CUSTOM IN-THE-EAR HEARING AID
K864180 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 9d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT SET-RPLA
K855233 · GTN
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT VET-RPLA
K855234 · GNA
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT PET-RPLA
K855235 · JSP
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT TST-RPLA
K855236 · GTN
Oxoid U.S.A., Inc.
Microbiology · 308d
Cleared Nov 04, 1986
SHEATH, ENDOSCOPE
K862059 · FGE
Endovations
Gastroenterology & Urology · 158d
Cleared Nov 04, 1986
EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER
K862164 · IYO
Hitachi Medical Corp. of America
Radiology · 151d
Cleared Nov 04, 1986
CRAIG NASO-GASTRIC TUBE HOLDER
K862855 · KNT
Henley Intl.
Gastroenterology & Urology · 98d
Cleared Nov 04, 1986
CARDIOSCAN WITH DOPPLER OPTION
K862913 · JOP
Interspec, Inc.
Cardiovascular · 95d
Cleared Nov 04, 1986
RESPIRONICS PTL REVIVEEASY
K863172 · CAO
Respironics, Inc.
Anesthesiology · 78d
Cleared Nov 04, 1986
MARTIN MEDICAL PRO-SCOPE ANOSCOPE
K863273 · KOA
Martin Medical
Gastroenterology & Urology · 71d
Cleared Nov 04, 1986
BIO-GUARD AB COATED CATHETER
K863354 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 67d
Cleared Nov 04, 1986
SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES
K863372 · DPT
Interspec, Inc.
Cardiovascular · 63d
Cleared Nov 04, 1986
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
K863385 · KNN
Cook Urological, Inc.
Physical Medicine · 62d
Cleared Nov 04, 1986
BILIARY BALLOON CATHETER
K863571 · FGE
Uresil Corp.
Gastroenterology & Urology · 53d
Cleared Nov 04, 1986
OSRAM ULTRAMED 400 W
K863937 · FTC
Osram GmbH
General & Plastic Surgery · 26d
Cleared Nov 04, 1986
TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY
K863958 · KOD
Cathaid, Inc.
Gastroenterology & Urology · 25d
Cleared Nov 04, 1986
MODEL XE-103 XENON/MASTER II
K863996 · IYT
Medi Nuclear Corp., Inc.
Radiology · 21d
Cleared Nov 04, 1986
ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE T
K864044 · FLL
Respiratory Support Products, Inc.
General Hospital · 19d
Cleared Nov 04, 1986
GENTLE FEEL
K864176 · HFS
Mali, Inc.
General Hospital · 11d
Cleared Nov 03, 1986
WALRUS: DOUBLE BALLOON SHUNTING CATHETER
K862190 · DWF
Medical Parameters, Inc.
Cardiovascular · 147d
Cleared Nov 03, 1986
EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS
K862260 · LCD
Syva Co.
Toxicology · 143d
Cleared Nov 03, 1986
TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN)
K862436 · BTO
Acutronic Medical Systems AG
Anesthesiology · 130d