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
140185–140208 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 31, 1987
JUMBO DIGITAL GAMMACAMERA, GCA-901A
K871175 · IYX
Toshiba Medical Systems
Radiology · 7d
Cleared Mar 30, 1987
SANASSAY IC TEST
K860996 · DAK
Scientific Sales Intl., Inc.
Immunology · 384d
Cleared Mar 30, 1987
VWF IMMUNOBLOT
K864701 · GGP
Ramco Laboratories, Inc.
Hematology · 118d
Cleared Mar 30, 1987
'EXMOOR' ZOELLNER SUCKER ENDS
K864937 · JOL
Exmoor Plastics , Ltd.
General Hospital · 104d
Cleared Mar 30, 1987
ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE
K864948 · LNK
Bio Quantum Technologies, Inc.
Gastroenterology & Urology · 103d
Cleared Mar 30, 1987
TRT TRANS-RECTAL TRANSDUCER
K870038 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 84d
Cleared Mar 30, 1987
DULBECCO'S MOD. EAGLE MED. NUT. MIX. F-12 #D2906
K870478 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
(DME) HYBRI-MAX W/L-GLUTAMINE PRODUCT NO. D6780
K870479 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
NCTC 135 MEDIUM HYBRI-MAX W/L-GLUTAMINE #N5138
K870480 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
(S-MEM) AUTO-MOD PRODUCT NO. M7272
K870481 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
(D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030
K870482 · KIP
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
WILLIAMS' MEDIUM E W/L-GLUTAMINE #W4125
K870483 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
HANKS' BALANCED SALTS (HBSS) NO. H1387
K870484 · KIP
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
LACTALBUMIN HYDROLYSATE (ELAH) NO. L3762
K870485 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509
K870486 · KIP
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
H-Y MEDIUM (DME:NCTC109, 7:1 MIX.) HYBRI-MAX H9014
K870487 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
RPMI 1640 MEDIUM DEFI. MODIFICATION NO. R7130
K870488 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755
K870489 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
(DME) W/1000 MG GLUCOSE/L NO. D4655
K870490 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002
K870491 · KIP
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
DULBECCO'S MODIFIED EAGLE MEDIUM BASE NO. D5030
K870492 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
NUTRIENT MIXTURE F-12 (HAM) (HEPES BUFFERED) N4388
K870493 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
RPMI-1640 HYBRI-MAX PRODUCT NO. R8005
K870494 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
(DME) AUTO-MOD MODIFIED FOR AUTOCLAVING #D5280
K870495 · KIT
Sigma Chemical Co.
Pathology · 55d