FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132049–132072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 1989
ANA-5 AUTOANTIBODY PROFILE KIT
K885224 · LKJ
Autoimmunity Diagnostics Corp.
Immunology · 115d
Cleared Apr 14, 1989
INTERSPEC APOGEE
K890173 · IYO
Interspec, Inc.
Radiology · 87d
Cleared Apr 14, 1989
REDI-VU MODEL RV-386
K890397 · LLZ
J.D. Technical Services
Radiology · 80d
Cleared Apr 14, 1989
WANG FRONT LOADING APPLICATOR
K890485 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 73d
Cleared Apr 14, 1989
TRANSCUTANEOUS O2/CO2 MONITOR
K890517 · LKD
Novametrix Medical Systems, Inc.
Anesthesiology · 74d
Cleared Apr 14, 1989
MODEL 3031
K890666 · LNH
Medical Advances, Inc.
Radiology · 64d
Cleared Apr 14, 1989
EMIT CONVENIENCE PACK: THYROXINE ASSAY
K890831 · KLI
Syva Co.
Chemistry · 52d
Cleared Apr 14, 1989
AQUA-BLANKET HYPER/HYPOHERMIA BLANKET
K890852 · ILO
Ati
Physical Medicine · 52d
Cleared Apr 14, 1989
AQUA-PAD FOR MOIST OR DRY HEAT THERAPY
K890853 · ILO
Ati
Physical Medicine · 52d
Cleared Apr 14, 1989
SURGICAL GOWN #2001
K891211 · FYA
Pro-Safe Professional Linens, Inc.
General Hospital · 38d
Cleared Apr 14, 1989
APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE
K891212 · FXO
Pro-Safe Professional Linens, Inc.
General Hospital · 38d
Cleared Apr 14, 1989
SURGICAL INSTRUMENT POUCH #M102
K891213 · KCT
Pro-Safe Professional Linens, Inc.
General Hospital · 38d
Cleared Apr 14, 1989
DENTAL SURGICAL WRAP #3007 A,B,C
K891214 · KCT
Pro-Safe Professional Linens, Inc.
General Hospital · 38d
Cleared Apr 14, 1989
FAST WRAP #M 101
K891215 · KCT
Pro-Safe Professional Linens, Inc.
General Hospital · 38d
Cleared Apr 14, 1989
HILARIS-NORI CERVIX APPLICATOR
K891377 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 36d
Cleared Apr 14, 1989
ORTHODONTIC WRAP-AROUND HAWLEY RETAINER
K891484 · EJF
American Orthodontics
Dental · 28d
Cleared Apr 14, 1989
C-89 GOLD BASE DENTAL ALLOY
K891516 · EJT
Macdonald Metals and Ceramics
Dental · 28d
Cleared Apr 14, 1989
M-77 GOLD BASE DENTAL ALLOY
K891530 · EJT
Macdonald Metals and Ceramics
Dental · 28d
Cleared Apr 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891636 · LYY
Broadland Rubber Industries Sdn Bhd
General Hospital · 28d
Cleared Apr 14, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891637 · LYY
Powercrest (M) Sdn. Bhd.
General Hospital · 28d
Cleared Apr 14, 1989
PATIENT EXAM GLOVE (LATEX) MFG. TIANJIN JI COUNTY
K891739 · LYY
Brilliant Ray Intl., Inc.
General Hospital · 23d
Cleared Apr 14, 1989
PATIENT EXAM GLOVES (LATEX) MFG. TIANJIN KANG BAO
K891740 · LYY
Brilliant Ray Intl., Inc.
General Hospital · 23d
Cleared Apr 14, 1989
EZ COMPLEMENT C1
K891904 · DAC
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
QUIK-DOT C REACTIVE PROTEIN
K892119 · DCK
Ampcor, Inc.
Immunology · 14d